ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound System

• K Number: K202683
• Device Name: ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound System
• Manufacturer: Siemens Medical Solutions, USA, Inc.
• Date Cleared: 2020-10-15 ( 30 days)
• Product Code: IYN ITX IYO LLZ OBJ OIJ
• Regulation Number: 892.1550

Intended Use

The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Musculoskeletal and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis, Vascular Imaging Applications and Analysis, Superficial Imaging Applications, Intraoperative Imaging Applications, Transcranial Imaging Applications. The ACUSON Freestyle Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body performed by an appropriately wained healthcare professional in a healthcare setting for the following conditions: Abdominal, Pediatric, Small Organ, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal (Superficial). The ultrasound imaging systems are intended for the following applications: Fetal. Abdominal. Intraoperative, Pediatric. Small Parts, Transcranial, OB/GYN (including monitoring of the ovarian follicle development), Cardiac. Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, small organ, neonatal cephalic, adult cephalic, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement: Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging". The ACUSON AcuNav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients. The ACUSON P200 ultrasound imaging system is intended for the following applications: Fetal, Abdominal, Pediatric, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Adult, Pediatric and Neonatal Cardiac, Pelvic, Neonatal Cephalic, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures; fetal, abdominal, pediatric, small organ, neonatal cephalic, cardiac (adult, pediatric and neonatal), trans-esophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculosketal (superficial) and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The ACUSON P500 ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including live), Pediatric, Small Parts, Transcranial, OB/GYN(useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Pelvic. Neonatal, Cardiac, Vascular(including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal, and Urology applications. The system also provides the ability to measure anatomical structures fetal, abdominal, small organ, transrectal, transvaginal, cardiovascular, peripheral vessel, musculoskeletal (conventional), and musculoskeletal (superficial) and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vascular Imaging." The ACUSON Acunav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other of adult and pediatric patients. For ACUSON NX3: The ACUSON NX3 ultrasound imaging system is intended for the following applications: Fetal Abdominal (including liver), Pediatric, Small Parts (Small Organ), Neonatal Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular (including Peripheral Vessel), Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. For ACUSON NX3 Elite: The ACUSON NX3 Elite ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Parts (Small Organ including intra-operative), Neonatal Cephalic, Adult Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac(including Transesophageal), Vascular (including Peripheral Vessel, intra-operative), Musculoskeletal, Superficial Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. Note: This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Medicine."

Device Description

The ACUSON Sequoia Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes, Panoramic Imaging, Contrast agent Imaging, Virtual Touch Strain Imaging, Virtual Touch - pSWE Imaging, Virtual Touch - SWE Imaging, syngo Velocity Vector Imaging, Custom Tissue Imaging, 3D/4D Volume Imaging and Harmonic Imaging on a Display. All of the transducers and the catheter-based transducers will follow Track 3 acoustic labeling (AIUM 1004, IEC 2007, AIUM/NEMA 2004a) and remain unchanged from the currently cleared ACUSON systems. Note: Some ACUSON Diagnostic Ultrasound configurations of components, accessories and/or software may vary from device brands and within device families. There are no modifications, additions or labeling changes to components, accessories and/or software for each device indicated. The ACUSON Diagnostic Ultrasound systems are intended to be used by trained medical professionals at various locations where patient care, evaluation, monitoring or research is performed.

Predicate Devices

K201462, K200585, K200644, K172162, K191922, K163396, K192835

Reference Devices

K201130, K201012

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging modes and measurement packages, with no mention of AI or ML capabilities.

Therapeutic

No
The stated intended use of the devices is for diagnostic imaging, providing images or signals for clinical diagnosis purposes, not for therapeutic intervention.

Diagnostic

Yes

The "Intended Use / Indications for Use" section repeatedly states that the systems provide information "for clinical diagnosis purposes" or are "intended for diagnostic imaging." Additionally, the "Device Description" section explicitly refers to the ACUSON Sequoia and other ACUSON systems as "diagnostic ultrasound system[s]."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "multi-purpose mobile, software controlled, diagnostic ultrasound system," indicating it includes hardware components for transmitting and receiving ultrasound data.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
• Device Function: The description clearly states that the ACUSON ultrasound systems "transmit and receive ultrasound echo data and display it... to form a two-dimensional (2D) image" of structures inside the body.
• Intended Use: The intended use describes imaging various anatomical sites within the patient's body (Fetal, Abdominal, Cardiac, etc.) and providing measurements and analysis based on these images.
• No Specimen Analysis: There is no mention of analyzing samples taken from the patient's body.

The device is a diagnostic imaging system that uses ultrasound technology to visualize internal structures, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

• ACUSON Sequoia Diagnostic Ultrasound System: The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Musculoskeletal and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
• ACUSON SC2000 Diagnostic Ultrasound System: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis Vascular Imaging Applications and Analysis Superficial Imaging Applications Intraoperative Imaging Applications Transcranial Imaging Applications
• ACUSON Freestyle Diagnostic Ultrasound System: The ACUSON Freestyle Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body performed by an appropriately trained healthcare professional in a healthcare setting for the following conditions: Abdominal, Pediatric, Small Organ, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal (Superficial).
• ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN (including monitoring of the ovarian follicle development), Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, transesophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculoskeletal (superficial) and neonatal cardiac } and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task force, Endorsed by the Society for Vascular Imaging". The ACUSON AcuNav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heard of adult and pediatric patients.
• ACUSON P200 Diagnostic Ultrasound System: The ACUSON P200 ultrasound imaging system is intended for the following applications: Fetal, Abdominal, Pediatric, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Adult, Pediatric and Neonatal Cardiac, Pelvic, Neonatal Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures; fetal, abdominal, pediatric, small organ, neonatal cephalic, cardiac (adult, pediatric and neonatal), transesophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculoskeletal (superficial) and calculations packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
• ACUSON P500 Ultrasound System: The ACUSON P500 ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver), Pediatric, Small parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Pelvic, Neonatal, Cardiac, IntraCardiac, Vascular (including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal, and Urology applications. The system also provides the ability to measure anatomical structures fetal, abdominal, small organ, transrectal, transvaginal, cardiovascular, peripheral vessel, musculoskeletal (conventional), and musculoskeletal (superficial) and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography: Carotid Intima-Media Thickness Task force, Endorsed by the Society for Vascular Imaging". The ACUSON Acunav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.
• ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System:
  • For ACUSON NX3: The ACUSON NX3 ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Organ), Neonatal Cephalic, Adult Cephalic. Transcranial. OB/GYN. Pelvic. Neonatal. Cardiac. Vascular (including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
  • For ACUSON NX3 Elite: The ACUSON NX3 Elite ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Parts (Small Organ including intra-operative), Neonatal Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac (including Transesophageal), Vascular (including Peripheral Vessel, intra-operative), Musculoskeletal, Superficial Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
  • The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. Note: This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography: Carotid Intima-Media Thickness Task force, Endorsed by the Society for Vascular Medicine".

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX, OBJ, LLZ, OIJ

Device Description

The ACUSON Sequoia Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes, Panoramic Imaging, Contrast agent Imaging, Virtual Touch Strain Imaging, Virtual Touch - pSWE Imaging, Virtual Touch - SWE Imaging, syngo Velocity Vector Imaging, Custom Tissue Imaging, 3D/4D Volume Imaging and Harmonic Imaging on a Display. All of the transducers and the catheter-based transducers will follow Track 3 acoustic labeling (AIUM 1004, IEC 2007, AIUM/NEMA 2004a) and remain unchanged from the currently cleared ACUSON systems. Note: Some ACUSON Diagnostic Ultrasound configurations of components, accessories and/or software may vary from device brands and within device families. There are no modifications, additions or labeling changes to components, accessories and/or software for each device indicated.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts (breast, testes, thyroid, penis, prostate etc.), OB/GYN (ovaries, follicles, uterus and other pelvic structures), Cardiac (heart, cardiac valves, great vessels), Pelvic, Vascular (carotid arteries, juggular veins, superficial and deep veins and arteries in arms, legs, and abdomen, peripheral vessel), Musculoskeletal (conventional and superficial), Transesophageal, Transrectal, Transvaginal, Transcranial (brain), Intraoperative, Urology.

Indicated Patient Age Range

Adult, Pediatric, Neonatal. Fetal.

Intended User / Care Setting

Appropriately trained healthcare professional in a clinical setting.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Nonclinical testing was conducted to verify and validate the Customer Requirement Specifications (CRS) for each listed ACUSON Diagnostic Ultrasound device. This testing included verifying compliance to IEC 62304:2006/A1:2016, IEC 62366-1:2015, and NEMA PS 3.1 - 3.20 (2016). No software or hardware modifications were made to the devices; thus, no new testing results are included in this Special 510(k) submission. The expanded labeling for Lung ultrasound imaging (LUS) is supported by clinical literature, and the device uses the same technology and operating principles as the predicate devices, so clinical studies were not required. Risk analysis was performed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K201462, K200585, K200644, K172162, K191922, K163396, K192835

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K201130, K201012

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

October 15, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Siemens Medical Solutions, USA, Inc. % Ms. Christine Dunbar Senior Regulatory Affairs Specialist 22010 South East 51st Street ISSAQUAH WA 98029

Re: K202683

Trade/Device Name: ACUSON Sequoia Diagnostic Ultrasound System. ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System, ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX, OBJ, LLZ, OIJ Dated: September 11, 2020 Received: September 15, 2020

Dear Ms. Dunbar:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

1

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K202683

Device Name

ACUSON Sequoia Diagnostic Ultrasound System

Indications for Use (Describe)

The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Musculoskeletal and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FORM FDA 3881 (7/17)

3

510 (k) Number (if known):

Device Name:

Intended Use:

ACUSON Sequoia Diagnostic Ultrasound System

Ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC
Abdominal		P	P	P		P	P		BMDC
Intraoperative
Intraoperative
Neurological
Pediatric		P	P	P	P	P	P		BMDC
Small Organ
(Note 1)		P	P	P		P	P		BMDC
Neonatal Cephalic		P	P	P		P	P		BMDC
Adult Cephalic		P	P	P		P	P		BMDC
Cardiac		P	P	P	P	P	P		BMDC
Trans-esophageal
Transrectal		P	P	P		P	P		BMDC
Transvaginal		P	P	P		P	P		BMDC	Volume Imaging
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC
Laparoscopic
Musculo-skeletal
Conventional		P	P	P		P	P		BMDC
Musculo-skeletal
Superficial		P	P	P		P	P		BMDC
Other (specify)

N = new indication; P = previously cleared by K200707

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

4

510 (k) Number (if known):

Device Name:	4V1 Phased Array Transducer
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as follows:
		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal	P	P	P	P		P	P		BMDC
Abdominal	P	P	P	P		P	P		BMDC
Intraoperative
Intraoperative
Neurological
Pediatric	P	P	P	P		P	P		BMDC
Small Organ
(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by K200707

Additional Comments:

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

5

510 (k) Number (if known):

| Device Name:
Intended Use: | | | | | | DAX Curved Array Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | |
|----------------------------------|-------------------|---|---|-----|-----|--------------------------------------------------------------------------------------------------------|----------------------|------------------------------|-----------------------|--------------------|
| | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMCD | |
| Abdominal | | P | P | P | | P | P | | BMCD | |
| Intraoperative | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMCD | |
| Small Organ
(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N = new indication; P = previously cleared by K200707

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

6

510 (k) Number (if known):

Device Name:

5C1 Curved Array Transducer

Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMCD
Abdominal		P	P	P		P	P		BMCD
Intraoperative
Intraoperative
Neurological
Pediatric		P	P	P		P	P		BMCD
Small Organ
(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by K200707

Additional Comments:

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

7

510 (k) Number (if known):

Device Name:

9C3 Curved Array Transducer

Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMCD
Abdominal		P	P	P		P	P		BMCD
Intraoperative
Intraoperative
Neurological
Pediatric		P	P	P		P	P		BMCD
Small Organ
(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional		P	P	P		P	P		BMCD
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by K200707

Additional Comments:

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

8

510 (k) Number (if known):

| Device Name:
Intended Use: | 18L6 Linear Array Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|----------------------------------|---------------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | | Mode of Operation | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMCD | |
| Small Organ
(Note 1) | | P | P | P | | P | P | | BMCD | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | | P | P | | BMCD | |
| Musculo-skeletal
Superficial | | P | P | P | | P | P | | BMCD | |
| Other (specify) | | | | | | | | | | |

N = new indication; P = previously cleared by K200707

Additional Comments:

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

9

510 (k) Number (if known):

Device Name:	14L5 Linear Array Transducer
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric		P	P	P		P	P		BMCD
Small Organ
(Note 1)		P	P	P		P	P		BMCD
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMCD
Laparoscopic
Musculo-skeletal
Conventional		P	P	P		P	P		BMCD
Musculo-skeletal
Superficial		P	P	P		P	P		BMCD
Other (specify)

N = new indication; P = previously cleared by K200707

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

10

510 (k) Number (if known):

Device Name: 10L4 Linear Array Transducer
Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (Specify)	Other (Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMCD
Abdominal		P	P	P		P	P		BMCD
Intraoperative
Intraoperative
Neurological
Pediatric		P	P	P		P	P		BMCD
Small Organ
(Note 1)		P	P	P		P	P		BMCD
Neonatal Cephalic		P	P	P		P	P		BMCD
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMCD
Laparoscopic
Musculo-skeletal
Conventional		P	P	P		P	P		BMCD
Musculo-skeletal
Superficial		P	P	P		P	P		BMCD
Other (specify)

N = new indication; P = previously cleared by K200707

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

11

510 (k) Number (if known):

Device Name: Intended Use:

9EC4 Endocavity Transducer Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal		P	P	P		P	P		BMCD
Transvaginal		P	P	P		P	P		BMCD
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by K200707

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

12

510 (k) Number (if known):

Device Name:	5V1 Phased Array Transducer
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric	P	P	P	P	P	P	P		BMCD
Small Organ
(Note 1)
Neonatal Cephalic
Adult Cephalic	P	P	P	P		P	P		BMCD
Cardiac	P	P	P	P	P	P	P		BMCD
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by K200707

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

13

510 (k) Number (if known):

| Device Name:

Intended Use:								8V3 Phased Array Transducer
	Ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal		P	P	P		P	P		BMCD
Intraoperative
Intraoperative
Neurological
Pediatric		P	P	P	P	P	P		BMCD
Small Organ
(Note 1)
Neonatal Cephalic		P	P	P		P	P		BMCD
Adult Cephalic
Cardiac		P	P	P	P	P	P		BMCD
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by K200707

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

14

510 (k) Number (if known):

| Device Name:
Intended Use: | CW2 Continuous Wave Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | Mode of Operation | | | | | | | | | |
| | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | P | | | | | |
| Small Organ
(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | P | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N = new indication; P = previously cleared by K200707

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

15

510 (k) Number (if known):

Device Name:	10V4 Phased Array Transducer
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric		P	P	P	P	P	P		BMCD
Small Organ
(Note 1)
Neonatal Cephalic		P	P	P	P	P	P		BMCD
Adult Cephalic
Cardiac		P	P	P	P	P	P		BMCD
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by K200707

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

16

510 (k) Number (if known):

Device Name:	18H6 Linear Array Transducer
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)		P	P	P		P	P		BMCD
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial		P	P	P		P	P		BMCD
Other (specify)

N = new indication; P = previously cleared by K200707

Additional Comments:

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

17

510 (k) Number (if known):

| Device Name:

Intended Use:						CW5 Continuous Wave Transducer			Ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel					P
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by K200707

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

18

510 (k) Number (if known):

Device Name:	7L2 Linear Array Transducer
Intended Use:		Ultrasound imaging or fluid flow analysis of the human body as follows:
		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal		P	P	P		P	P		BMCD
Intraoperative
Intraoperative
Neurological
Pediatric		P	P	P		P	P		BMCD
Small Organ
(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMCD
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by K200707

Additional Comments:

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

19

510 (k) Number (if known):

Device Name:	11M3 Curved Array Transducer
Intended Use:		Ultrasound imaging or fluid flow analysis of the human body as follows:
		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric		P	P	P		P	P		BMCD
Small Organ
(Note 1)
Neonatal Cephalic		P	P	P		P	P		BMCD
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by K200707

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

20

510 (k) Number (if known):

Device Name: 9VE4 Curved Endovaginal Mechanical 3D Transducer Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal		N	N	N		N	N		BMCD	Volume Imaging
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by K200707

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

21

Indications for Use

510(k) Number (if known) K202683

Device Name

ACUSON SC2000 Diagnostic Ultrasound System

Indications for Use (Describe)

The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The typical examinations performed using the SC2000 Ultrasound System are:

Cardiac Imaging Applications and Analysis

The system transmits ultrasound energy into adult, pediatric, neonatal, and fetal cardiac patients creating 2D (B), 3D, MMode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heail, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

The system also supports catheters which are intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Vascular Imaging Applications and Analysis

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid atteries or juggler veins in the neck; superficial and deep veins and arteries in the arms and legs and abdomen; and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchromizing the diastolic and systolic capture of ultrasound images. The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Superficial Imaging Applications

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

Intraoperative Imaging Applications

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during intraoperative procedures.

Transcranial Imaging Applications

The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Dopler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence of pathology. The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

22

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

23

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K202683

Device Name

ACUSON Freestyle Diagnostic Ultrasound System

Type of Use (Select one or both, as applicable)

Indications for Use (Describe)

The ACUSON Freestyle Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body performed by an appropriately wained healthcare professional in a healthcare setting for the following conditions: Abdominal, Pediatric, Small Organ, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal (Superficial),

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

24

510 (k) Number (if known):

Device Name:

ACUSON Freestyle™ Diagnostic Ultrasound System

Intended Use:

Diagnostic imaging or fluid flow analysis of the human body as follows:

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify)
(Note 2) | Other
(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | | | | P | P | | | |
| Intraoperative | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | | | | P | P | | | |
| Small Organ
(Note 1) | | P | | | | P | P | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | | | | P | P | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | | P | P | | | |
| Musculo-skeletal
Superficial | | P | P | P | | P | P | | | |
| Other (specify) | | | | | | | | | | |

N = new indication; P = previously cleared by K162417, Blank = Not Claimed

Additional Comments:
Note 1

For example: breast, testes, thyroid, penis etc.

Note 2 B-mode and PWD mode or Color Doppler and PW mode

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

25

510 (k) Number (if known):

| Device Name:
Intended Use: | L8-3 Linear Array Transducer
Diagnostic imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|----------------------------------|---------------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------------------|--------------------|
| | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify)
(Note 2) | Other
(Specify) |
| Clinical Application | | Mode of Operation | | | | | | | | |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | | | | P | P | | | |
| Intraoperative | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | | | | P | P | | | |
| Small Organ
(Note 1) | | P | | | | P | P | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | | | | P | P | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | | | | P | P | | | |
| Musculo-skeletal
Superficial | | P | | | | P | P | | | |
| Other (specify) | | | | | | | | | | |

N = new indication; P = previously cleared by K162417, Blank = Not Claimed

Additional Comments:

For example: breast, testes, thyroid, penis etc. Note 1

B-mode and PWD mode or Color Doppler and PW mode Note 2

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

26

510 (k) Number (if known):

| Device Name:
Intended Use: | L13-5 Linear Array Transducer
Diagnostic imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | | |
|----------------------------------|----------------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------------------|--------------------|--|--|
| | | Mode of Operation | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify)
(Note 2) | Other
(Specify) | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | P | | | | P | P | | | | | |
| Intraoperative | | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | | |
| Pediatric | | P | | | | P | P | | | | | |
| Small Organ
(Note 1) | | P | | | | P | P | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral vessel | | P | | | | P | P | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | | | | P | P | | | | | |
| Musculo-skeletal
Superficial | | P | | | | P | P | | | | | |
| Other (specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by K162417, Blank = Not Claimed

Additional Comments:

For example: breast, testes, thyroid, penis etc. Note 1

Note 2 B-mode and PWD mode or Color Doppler and PW mode

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

27

510 (k) Number (if known):

| Device Name:
Intended Use: | | L17-5 Linear Array Transducer
Diagnostic imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
|----------------------------------|-------------------|----------------------------------------------------------------------------------------------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------------------|--------------------|--|--|
| | Mode of Operation | | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify)
(Note 2) | Other
(Specify) | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | N | | | | N | N | | | | | |
| Intraoperative | | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | | |
| Pediatric | | N | | | | N | N | | | | | |
| Small Organ
(Note 1) | | N | | | | N | N | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral vessel | | N | | | | N | N | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | N | | | | N | N | | | | | |
| Musculo-skeletal
Superficial | | N | | | | N | N | | | | | |
| Other (specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by K162417, Blank = Not Claimed

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis etc.

Note 2 B-mode and PWD mode or Color Doppler and PW mode

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

28

510 (k) Number (if known):

Device Name:

C5-2 Curvillinear Array Transducer

Diagnostic imaging or fluid flow analysis of the human body as follo

Intended Use:	Diagnostic imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)
(Note 2)	Other
(Specify)
Ophthalmic
Fetal
Abdominal		P				P	P
Intraoperative
Intraoperative
Neurological
Pediatric		P				P	P
Small Organ
(Note 1)		P				P	P
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P				P	P
Laparoscopic
Musculo-skeletal
Conventional		P				P	P
Musculo-skeletal
Superficial		P				P	P
Other (specify)

N = new indication; P = previously cleared by K162417, Blank = Not Claimed

Additional Comments:

For example: breast, testes, thyroid, penis etc. Note 1

Note 2 B-mode and PWD mode or Color Doppler and PW mode

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

29

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K202683

Device Name

S1000, S2000, S3000 Diagnostic Ultrasound Systems

Indications for Use (Describe)

The ultrasound imaging systems are intended for the following applications: Fetal. Abdominal. Intraoperative, Pediatric. Small Parts, Transcranial, OB/GYN (including monitoring of the ovarian follicle development), Cardiac. Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, small organ, neonatal cephalic, adult cephalic, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for climical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement: Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

The ACUSON AcuNav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

Transducer Indications for Use are on the attached pages.

Type of Use (Select one or both, as applicable)	X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
-------------------------------------------------	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

[e-mail]

"An agency may not conduct or sponsor and a person is not required to respond to a collection of

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid QMB number."

EF

30

510 (k) Number (if known): Device Name: Intended Use:

ACUSON S1000, S2000 and S3000 Ultrasound Systems Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC
Abdominal		P	P	P	P	P	P		BMDC
Intraoperative		P	P	P	P	P	P		BMDC	Note 2
Intraoperative
Neurological
Pediatric		P	P	P	P	P	P		BMDC
Small Organ		P	P	P	P	P	P		BMDC	Note 1
Neonatal Cephalic		P	P	P	P	P	P		BMDC
Adult Cephalic		P	P	P	P	P	P		BMDC
Cardiac		P	P	P	P	P	P		BMDC
Trans-esophageal		P	P	P	P	P	P		BMDC
Transrectal		P	P	P		P	P		BMDC
Transvaginal		P	P	P		P	P		BMDC
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC
Laparoscopic
Musculo-skeletal
Conventional		P	P	P	P	P	P		BMDC
Musculo-skeletal
Superficial		P	P	P	P	P	P		BMDC
Other (specify)
Neonatal Cardiac		P	P	P	P	P	P		BMDC

N = new indication; P = previously cleared by FDA K162243

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 For example: vascular, abdominal

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)

31

510 (k) Number (if known): Device Name:

12L4 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric	P	P	P	P		P	P		BMDC
Small Organ	P	P	P	P		P	P		BMDC	Note 1
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P		P	P		BMDC
Laparoscopic
Musculo-skeletal
Conventional	P	P	P	P		P	P		BMDC
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K162243

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 For example: vascular, abdominal

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)

32

510 (k) Number (if known): Device Name:

CW2 Probe for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal					P
Abdominal					P
Intraoperative					P				Note 2
IntraoperativeNeurological
Pediatric					P
Small Organ					P				Note 1
Neonatal Cephalic					P
Adult Cephalic					P
Cardiac					P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel					P
Laparoscopic
Musculo-skeletalConventional					P
Musculo-skeletalSuperficial					P
Other (specify)

N = new indication; P = previously cleared by FDA K162243

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: vascular, abdominal

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

33

510 (k) Number (if known): Device Name:

CW5 Probe for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal					P
Abdominal					P
Intraoperative					P					Note 2
Intraoperative
Neurological					P
Pediatric					P
Small Organ					P					Note 1
Neonatal Cephalic					P
Adult Cephalic					P
Cardiac					P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel					P
Laparoscopic
Musculo-skeletal
Conventional					P
Musculo-skeletal
Superficial					P
Other (specify)

N = new indication; P = previously cleared by FDA K162243

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: vascular, abdominal

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)

34

510 (k) Number (if known): Device Name:

EC9-4 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal	P	P	P	P		P	P		BMDC
Abdominal	P	P	P	P		P	P		BMDC
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ		P	P	P		P	P		BMDC	Note 1
Neonatal Cephalic		P	P	P		P	P		BMDC
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal		P	P	P		P	P		BMDC
Transvaginal		P	P	P		P	P		BMDC
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K162243

Additional Comments:

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

Note 2 For example: vascular, abdominal

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)

35

510 (k) Number (if known): Device Name:

MC9-4 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC
Abdominal		P	P	P		P	P		BMDC
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ		P	P	P		P	P		BMDC	Note 1
Neonatal Cephalic		P	P	P		P	P		BMDC
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal		P	P	P		P	P		BMDC
Transvaginal		P	P	P		P	P		BMDC
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K162243

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 For example: vascular, abdominal

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)

36

510 (k) Number (if known): Device Name:

9L4 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric		P	P	P		P	P		BMDC
Small Organ		P	P	P		P	P		BMDC	Note 1
Neonatal Cephalic		P	P	P		P	P		BMDC
Adult Cephalic		P	P	P		P	P		BMDC
Cardiac		P	P	P		P	P		BMDC
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC
Laparoscopic
Musculo-skeletal
Conventional		P	P	P		P	P		BMDC
Musculo-skeletal
Superficial		P	P	P		P	P		BMDC
Other (specify)

N = new indication; P = previously cleared by FDA K162243

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: vascular, abdominal

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)

37

510 (k) Number (if known): Device Name:

14L5 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ	P	P	P	P		P	P		BMDC	Note 1
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P		P	P		BMDC
Laparoscopic
Musculo-skeletal
Conventional	P	P	P	P		P	P		BMDC
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K162243

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 For example: vascular, abdominal

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)

38

510 (k) Number (if known): Device Name:

4P1 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC
Abdominal		P	P	P	P	P	P		BMDC
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic		P	P	P	P	P	P		BMDC
Cardiac		P	P	P	P	P	P		BMDC
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K162243

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 For example: vascular, abdominal

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)

39

510 (k) Number (if known):

Device Name:

6C2 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC
Abdominal		P	P	P	P	P	P		BMDC
Intraoperative
Intraoperative
Neurological
Pediatric		P	P	P	P	P	P		BMDC
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K162243 Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: vascular, abdominal

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40

510 (k) Number (if known):

Device Name:

4C1 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

| | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|----------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | |
| Abdominal | | P | P | P | P | P | P | | BMDC | |
| Intraoperative | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | P | P | P | P | P | P | | BMDC | Note 2 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | BMDC | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N = new indication; P = previously cleared by FDA K162243

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: vascular, abdominal

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)

41

510 (k) Number (if known): Device Name:

6C1 HD Transducer for use with ACUSON S2000 and S3000 Ultrasound Systems

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC
Abdominal		P	P	P	P	P	P		BMDC
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ		P	P	P	P	P	P		BMDC	Note 2
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		BMDC
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K162243

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 For example: vascular, abdominal

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)

42

510 (k) Number (if known):

Device Name:

8C3 HD Transducer for use with ACUSON S2000 and S3000 Ultrasound Systems

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC
Abdominal		P	P	P		P	P		BMDC
Intraoperative
Intraoperative
Neurological
Pediatric		P	P	P		P	P		BMDC
Small Organ		P	P	P		P	P		BMDC	Note 2
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K162243

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: vascular, abdominal

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)

43

510 (k) Number (if known):

Device Name:

4V1 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC
Abdominal		P	P	P		P	P		BMDC
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K162243

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: vascular, abdominal

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)

44

510 (k) Number (if known):

Device Name:

10V4 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC
Abdominal		P	P	P	P	P	P		BMDC
Intraoperative
Intraoperative
Neurological
Pediatric		P	P	P	P	P	P		BMDC
Small Organ
Neonatal Cephalic		P	P	P	P	P	P		BMDC
Adult Cephalic
Cardiac		P	P	P	P	P	P		BMDC
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K162243

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: vascular, abdominal

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45

510 (k) Number (if known): _

Device Name:

14L5 SP Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems

Indications For Use:

Diagnostic imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative	P	P	P	P		P	P		BMDC	Note 2
Intraoperative
Neurological
Pediatric
Small Organ	P	P	P	P		P	P		BMDC	Note 1
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P		P	P		BMDC
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P		P	P		BMDC
Laparoscopic
Musculo-skeletal
Conventional	P	P	P	P		P	P		BMDC
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K162243

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: vascular, abdominal

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)

46

510 (k) Number (if known):

Device Name:

7CF2 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC
Abdominal		P	P	P		P	P		BMDC
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K162243

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 For example: vascular, abdominal

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)

47

510 (k) Number (if known):

Device Name:

7CF1 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC
Abdominal		P	P	P		P	P		BMDC
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K162243

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: vascular, abdominal

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)

48

510 (k) Number (if known):

Device Name:

9EVF4 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ
Neonatal Cephalic		P	P	P		P	P		BMDC
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal		P	P	P		P	P		BMDC
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K162243 Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: vascular, abdominal

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)

49

510 (k) Number (if known): Device Name:

V5Ms Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal	P	P	P	P	P	P		BMDC
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K162243

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 For example: vascular, abdominal

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)

50

510 (k) Number (if known): Device Name:

18L6 HD Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ		P	P	P	P	P	P	P		BMDC	Note 1
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P	P		BMDC
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P	P		BMDC
Laparoscopic
Musculo-skeletal
Conventional		P	P	P	P	P	P	P		BMDC
Musculo-skeletal
Superficial		P	P	P	P	P	P	P		BMDC
Other (specify)

N = new indication; P = previously cleared by FDA K162243

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: vascular, abdominal

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)

51

510 (k) Number (if known): Device Name:

8V3 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal	P	P	P	P	P	P	P		BMDC
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric	P	P	P	P	P	P	P		BMDC
Small Organ
Neonatal Cephalic	P	P	P	P	P	P	P		BMDC
Adult Cephalic
Cardiac	P	P	P	P	P	P	P		BMDC
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)
Neonatal Cardiac	P	P	P	P	P	P	P		BMDC

N = new indication; P = previously cleared by FDA K162243 Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 For example: vascular, abdominal

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)

52

510 (k) Number (if known): Device Name:

4V1c Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC
Abdominal		P	P	P	P	P	P		BMDC
Intraoperative		P	P	P	P	P	P		BMDC	Note 2
Intraoperative
Neurological		P	P	P	P	P	P		BMDC
Pediatric		P	P	P	P	P	P		BMDC
Small Organ
Neonatal Cephalic
Adult Cephalic		P	P	P	P	P	P		BMDC
Cardiac		P	P	P	P	P	P		BMDC
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)
Neonatal Cardiac		P	P	P	P	P	P		BMDC

N = new indication; P = previously cleared by FDA K162243 Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 For example: vascular, abdominal

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)

53

510 (k) Number (if known): Device Name:

EV-8C4 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC
Abdominal		P	P	P	P	P	P		BMDC
Intraoperative
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal		P	P	P	P	P	P		BMDC
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K162243

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 For example: vascular, abdominal

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)

54

510 (k) Number (if known):

Device Name:

V7MTransducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined
(Specify) *	Harmonic
Imaging	Other
(Specify)
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P		P	P
Intraoperative
Intraoperative
Neurological
Pediatric	P	P	P	P	P	P	P		P	P
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P		P	P
Trans-esophageal	P	P	P	P	P	P	P		P	P
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vessel
Laparoscopic
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Other (specify)

N = new indication; P = previously cleared by FDA K162243

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color, Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)

55

510 (k) Number (if known): Device Name:

AcuNav 8F Ultrasound Catheter for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems

Intended Use:

The AcuNav™ Ultrasound Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined
(Specify) *	Other:
Harmonic
Imaging
Ophthalmic
Fetal
Abdominal
Intraoperative
(Vascular)
Intraoperative
(Neurological)
Pediatric	P	P	P	P	P	P	P		P
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P		P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal	P	P	P	P	P	P	P		P
Peripheral Vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (Intra-Cardiac)	P	P	P	P	P	P	P		P

N = new indication; P = previously cleared by FDA K162243

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)

56

510 (k) Number (if known): Device Name:

AcuNav 10F Ultrasound Catheter for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems

Intended Use:

The AcuNav™ Ultrasound Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined
(Specify) *	Other:
Harmonic
Imaging
Ophthalmic
Fetal
Abdominal
Intraoperative
(Vascular)
Intraoperative
(Neurological)
Pediatric	P	P	P	P	P	P	P		P
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P		P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal	P	P	P	P	P	P	P		P
Peripheral Vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (Intra-Cardiac)	P	P	P	P	P	P	P		P

N = new indication; P = previously cleared by FDA K162243

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Colo Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)

57

Indications for Use

510(k) Number (if known)

K202683

Device Name ACUSON P200 Diagnostic Ultrasound System

Indications for Use (Describe)

The ACUSON P200 ultrasound imaging system is intended for the following applications: Fetal, Abdominal, Pediatric, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Adult, Pediatric and Neonatal Cardiac, Pelvic, Neonatal Cephalic, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures; fetal, abdominal, pediatric, small organ, neonatal cephalic, cardiac (adult, pediatric and neonatal), trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculosketal (superficial) and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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58

510 (k) Number (if known):

Device Name:

ACUSON P200 Diagnostic Ultrasound System

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

Ultrasound imaging or fluid flow analysis of the human body as follows.

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal	P	P	P		P	P	BMDC
Abdominal	P	P	P		P	P	BMDC
Intraoperative
Intraoperative
Neurological
Pediatric	P	P	P	P	P	P	BMDC
Small Organ (Note 1)	P	P	P		P	P	BMCD
Neonatal Cephalic	P	P	P		P	P	BMCD
Adult Cephalic
Cardiac	P	P	P	P	P	P	BMCD
Trans-esophageal	P	P	P	P	P	P	BMCD
Transrectal	P	P	P		P	P	BMCD
Transvaginal	P	P	P		P	P	BMCD
Transurethral
Intravascular
Peripheral vessel
(Note 2)	P	P	P	P	P	P	BMCD
Laparoscopic
Musculo-skeletal
Conventional	P	P	P		P	P	BMCD
Musculo-skeletal
Superficial	P	P	P		P	P	BMCD
Other (specify)

N = new indication; P = previously cleared by FDA K180067; K180039; K187357

Note 1 Note 2 For example: Breast, Thyroid, Testis For example: Carotid, Arterial, Venous

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59

510 (k) Number (if known):

Device Name: Intended Use:

4V1 Phased Array Transducer

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal	P	P	P		P	P	BMDC
Abdominal	P	P	P		P	P	BMDC
Intraoperative
Intraoperative
Neurological
Pediatric	P	P	P		P	P	BMDC
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
(Note 2)
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K180067

For example: Breast, Thyroid, Testis
For example: Carotid, Arterial, Venous Note 1 Note 2

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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60

510 (k) Number (if known):

Device Name:

5V1 Phased Array Transducer

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric	P	P	P	P	P	P	BMCD
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	BMCD
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
(Note 2)
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K180067

Note 1
Note 2

For example: Breast, Thyroid, Testis
For example: Carotid, Arterial, Venous

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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510 (k) Number (if known):

Device Name:

8V3 Phased Array Transducer

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	BMCD
Intraoperative
Intraoperative
Neurological
Pediatric	P	P	P	P	P	P	BMCD
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	BMCD
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
(Note 2)
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K180067

Note 1
Note 2

For example: Breast, Thyroid, Testis
For example: Carotid, Arterial, Venous

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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62

510 (k) Number (if known):

Device Name:

10V4 Curved Array Transducer

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	BMCD
Intraoperative
Intraoperative
Neurological
Pediatric	P	P	P		P	P	BMCD
Small Organ (Note 1)
Neonatal Cephalic	P	P	P		P	P	BMCD
Adult Cephalic
Cardiac	P	P	P	P	P	P	BMCD
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
(Note 2)
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K183575

Note 1
Note 2

For example: Breast, Thyroid, Testis
For example: Carotid, Arterial, Venous

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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63

510 (k) Number (if known):

Device Name:

CW2 Continuous Wave Transducer

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric				P
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac				P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
(Note 2)
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K183575

Note 1
Note 2 For example: Breast, Thyroid, Testis
For example: Carotid, Arterial, Venous

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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64

510 (k) Number (if known):

Device Name: Intended Use:

CW5 Continuous Wave Transducer

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric				P
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
(Note 2)				P
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K183575

Note 1 For example: Breast, Thyroid, Testis Note 2 For example: Carotid, Arterial, Venous

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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65

510 (k) Number (if known):

Device Name: Intended Use:

10L4 Linear Array Transducer

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal	P	P	P	P	P	P	BMCD
Abdominal	P	P	P	P	P	P	BMCD
Intraoperative
Intraoperative
Neurological
Pediatric	P	P	P	P	P	P	BMCD
Small Organ (Note 1)	P	P	P		P	P	BMCD
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
(Note 2)	P	P	P	P	P	P	BMCD
Laparoscopic
Musculo-skeletal
Conventional	P	P	P		P	P	BMCD
Musculo-skeletal
Superficial	P	P	P		P	P	BMCD
Other (specify)

N = new indication; P = previously cleared by FDA K180067

Note 1 For example: Breast, Thyroid, Testis Note 2 For example: Carotid, Arterial, Venous

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510 (k) Number (if known):

Device Name:

14L5 Linear Array Transducer

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric	P	P	P		P	P	BMCD
Small Organ (Note 1)	P	P	P		P	P	BMCD
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
(Note 2)	P	P	P		P	P	BMCD
Laparoscopic
Musculo-skeletal
Conventional	P	P	P		P	P	BMCD
Musculo-skeletal
Superficial	P	P	P		P	P	BMCD
Other (specify)

N = new indication; P = previously cleared by FDA K180067

Note 1
Note 2

For example: Breast, Thyroid, Testis
For example: Carotid, Arterial, Venous

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67

510 (k) Number (if known):

Device Name:

18L6 Linear Array Transducer

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric	P	P	P		P	P	BMCD
Small Organ (Note 1)	P	P	P		P	P	BMCD
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
(Note 2)
Laparoscopic
Musculo-skeletal
Conventional	P	P	P		P	P	BMCD
Musculo-skeletal
Superficial	P	P	P		P	P	BMCD
Other (specify)

N = new indication; P = previously cleared by FDA K180067

Note 1
Note 2

For example: Breast, Thyroid, Testis For example: Carotid, Arterial, Venous

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510 (k) Number (if known):

Device Name:

5C1 Curved Array Transducer

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal	P	P	P		P	P	BMCD
Abdominal	P	P	P		P	P	BMCD
Intraoperative
Intraoperative
Neurological
Pediatric	P	P	P		P	P	BMCD
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
(Note 2)
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K180067

Note 1
Note 2 For example: Breast, Thyroid, Testis
For example: Carotid, Arterial, Venous

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69

510 (k) Number (if known):

Device Name:

9C3 Curved Array Transducer

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal	P	P	P		P	P	BMCD
Abdominal	P	P	P		P	P	BMCD
Intraoperative
Intraoperative
Neurological
Pediatric	P	P	P		P	P	BMCD
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
(Note 2)
Laparoscopic
Musculo-skeletal
Conventional	P	P	P		P	P	BMCD
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K180067

Note 1
Note 2 For example: Breast, Thyroid, Testis
For example: Carotid, Arterial, Venous

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70

510 (k) Number (if known):

Device Name:

9EC4 Endocavity Transducer

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal	P	P	P		P	P	BMCD
Transvaginal	P	P	P		P	P	BMCD
Transurethral
Intravascular
Peripheral vessel
(Note 2)
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K180067

Note 1
Note 2

For example: Breast, Thyroid, Testis
For example: Carotid, Arterial, Venous

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71

510 (k) Number (if known):

Device Name:

V5Ms Multiplane TEE Transducer

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal	P	P	P	P	P	P	BMCD
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
(Note 2)
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K183575

Note 1
Note 2

For example: Breast, Thyroid, Testis
For example: Carotid, Arterial, Venous

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Indications for Use

510(k) Number (if known)

K202683

Device Name ACUSON P500 Ultrasound System

Indications for Use (Describe)

The ACUSON P500 ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including live), Pediatric, Small Parts, Transcranial, OB/GYN(useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Pelvic. Neonatal, Cardiac, Vascular(including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal, and Urology applications.

The system also provides the ability to measure anatomical structures fetal, abdominal, small organ, transrectal, transvaginal, cardiovascular, peripheral vessel, musculoskeletal (conventional), and musculoskeletal (superficial) and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system.

This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vascular Imaging."

The ACUSON Acunav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other of adult and pediatric patients.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
----------------------------------------------	---------------------------------------------

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73

510(k) Number (if known):

Device Name: Intended Use:

ACUSON P500™ Ultrasound System
Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
( Track1
Only)	Specific
(Tracks11& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	BMDC	Note 2, 3, 4, 11, 12, 16
	Abdominal	P	P	P	P	P	P	BMDC	Note 2, 3, 4, 11, 12, 16
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric
	SmallOrgan
(Note 1)	P	P	P		P	P	BMDC	Note 2, 3, 4, 9, 11, 12, 13, 16
	Neonatal Cephalic				N
	Adult Cephalic				N
	Trans-rectal	P	P	P		P	P	BMDC	Note 2, 3, 4, 11, 12, 16
	Trans-vaginal	P	P	P		P	P	BMDC	Note 2, 3, 4, 11, 12, 16
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)	P	P	P		P	P	BMDC	Note 2, 3, 4, 9, 11, 12, 13, 16
	Musculo-skel.
(Superfic)	P	P	P		P	P	BMDC	Note 2, 3, 4, 9, 11, 12, 13, 16
	Intra -vascular
	Other
(Specify)
	Cardiac Adult	P	P	P	P	P	P	BMDC	Note 2, 4, 6, 7, 8, 10, 12, 16
Cardiac	Cardiac Pediatric	N	N	N	N	N	N	BMDC	Note 2, 4, 6, 7, 10, 12, 16
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-Cardiac	N	N	N	N	N	N	BMDC	Note 2, 4, 10, 12, 14, 15, 16
	Other (Specify)
Peripheral	Peripheral vessel	P	P	P	N	P	P	BMDC	Note 2, 3, 4, 9, 11, 12, 13, 16
Vessel	Other (Specify)

N = new indication; P = previously cleared

Note 1	For example: breast, testes, thyroid, prostate, etc.
Note 2	Dynamic TCE Technology
Note 3	Advanced SieClear
Note 4	eSielmage
Note 5	For example: abdominal, vascular (upper and lower)
Note 6	Stress Echo
Note 7	eSieMeasure
Note 8	eSieScan
Note 9	AHP
Note 10	DTI
Note 11	Panoramic 2D Imaging (SieScape)
Note 12	Clarify VE
Note 13	Needle Visualization
Note 14	Intracardiac Echocardiography (ICE) Imaging
Note 15	CARTOSOUND Communication
Note 16	Probe Saver

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

510(k)_

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74

510(k) Number (if known):

| Device Name: | | P4-2 Phased Array Transducer for use with:
ACUSON P500™ Ultrasound System | | | | | | | | |
|-----------------------------|-------------------------------|------------------------------------------------------------------------------|---|-----|-----|------------------|------------------|-----------------------|--------------------------------|--|
| Intended Use: | | Diagnostic imaging or fluid flow analysis of the human body as follows: | | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | | | |
| Other
(Track1
Only) | Specific
(Tracks1& 3) | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Combined
(Specify) | Other
(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | P | P | P | P | P | P | BMDC | Note 2, 4, 12,16 | |
| | Abdominal | P | P | P | P | P | P | BMDC | Note 2, 4, 12,16 | |
| | Intra-operative | | | | | | | | | |
| | Intra-operative
(Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| Fetal
Imaging
& Other | Pediatric | | | | | | | | | |
| | SmallOrgan
(Note 1) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.
(non-Card.) | | | | | | | | | |
| | Musculo-skel.
(Convent.) | | | | | | | | | |
| | Musculo-skel.
(Superfic) | | | | | | | | | |
| | Intra-vascular | | | | | | | | | |
| | Other
(Specify) | | | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | BMDC | Note 2, 4, 6, 7, 8, 10, 12, 16 | |
| Cardiac | Cardiac Pediatric | | | | | | | | | |
| | Intra-vascular
(Cardiac) | | | | | | | | | |
| | Trans-esophageal
(Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel
(Note 5) | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |

N = new indication; P = previously cleared K150050

Note 1	For example: breast, testes, thyroid, prostate, etc.
Note 2	Dynamic TCE Technology
Note 3	Advanced SieClear
Note 4	eSielmage
Note 5	For example: abdominal, vascular (upper and lower)
Note 6	Stress Echo
Note 7	eSieMeasure
Note 8	eSieScan
Note 9	AHP
Note 10	DTI
Note 11	Panoramic 2D Imaging (SieScape)
Note 12	Clarify VE
Note 13	Needle Visualization
Note 14	Intracardiac Echocardiography (ICE) Imaging
Note 15	CARTOSOUND Communication
Note 16	Probe Saver

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k)_

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75

510(k) Number (if known):

Device Name: CH5-2 Curved Array Transducer for use with:
ACUSON P500™ Ultrasound System Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
( Track1
Only)	Specific
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	BMDC	Note 2, 3, 4, 11, 12, 16
	Abdominal	P	P	P		P	P	BMDC	Note 2, 3, 4, 11, 12, 16
	Intra-operative
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric
Imaging
& Other	SmallOrgan
(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)	P	P	P		P	P	BMDC	Note 2, 3, 4, 11, 12, 16
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
(Note 5)	P	P	P		P	P	BMDC	Note 2, 3, 4, 11, 12, 16
Vessel	Other (Specify)

N = new indication; P = previously cleared K150050

Note 1	For example: breast, testes, thyroid, prostate, etc.
Note 2	Dynamic TCE Technology
Note 3	Advanced SieClear
Note 4	eSielmage
Note 5	For example: abdominal, vascular (upper and lower)
Note 6	Stress Echo
Note 7	eSieMeasure
Note 8	eSieScan
Note 9	AHP
Note 10	DTI
Note 11	Panoramic 2D Imaging (SieScape)
Note 12	Clarify VE
Note 13	Needle Visualization
Note 14	Intracardiac Echocardiography (ICE) Imaging
Note 15	CARTOSOUND Communication
Note 16	Probe Saver

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76

510(k) Number (if known):

| Device Name: | | VF10-5 Linear Array Transducer for use with:
ACUSON P500™ Ultrasound System | | | | | | | | |
|-----------------------------|-------------------------------|--------------------------------------------------------------------------------|---|-----|-----|------------------|------------------|-----------------------|---------------------------------|--|
| Intended Use: | | Diagnostic imaging or fluid flow analysis of the human body as follows: | | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | | | |
| Other
(Track1
Only) | Specific
(Tracks 1& 3) | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Combined
(Specify) | Other
(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative | | | | | | | | | |
| | Intra-operative
(Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| Fetal
Imaging
& Other | Pediatric | | | | | | | | | |
| | SmallOrgan
(Note 1) | P | P | P | | P | P | BMDC | Note 2, 3, 4, 9, 11, 12, 13, 16 | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.
(non-Card.) | | | | | | | | | |
| | Musculo-skel.
(Convent.) | P | P | P | | P | P | BMDC | Note 2, 3, 4, 9, 11, 12, 13, 16 | |
| | Musculo-skel.
(Superfic) | | | | | | | | | |
| | Intra-vascular | | | | | | | | | |
| | Other
(Specify) | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | |
| | Intra-vascular
(Cardiac) | | | | | | | | | |
| | Trans-esophageal
(Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| Peripheral | Peripheral vessel
(Note 5) | P | P | P | | P | P | BMDC | Note 2, 3, 4, 9, 11, 12, 13, 16 | |
| Vessel | Other (Specify) | | | | | | | | | |

N = new indication; P = previously cleared K150050

Note 1	For example: breast, testes, thyroid, prostate, etc.
Note 2	Dynamic TCE Technology
Note 3	Advanced SieClear
Note 4	eSielmage
Note 5	For example: abdominal, vascular (upper and lower)
Note 6	Stress Echo
Note 7	eSieMeasure
Note 8	eSieScan
Note 9	AHP
Note 10	DTI
Note 11	Panoramic 2D Imaging (SieScape)
Note 12	Clarify VE
Note 13	Needle Visualization
Note 14	Intracardiac Echocardiography (ICE) Imaging
Note 15	CARTOSOUND Communication
Note 16	Probe Saver

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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• 510(k)_

77

510(k) Number (if known):

Device Name: EC9-4 Curved Array Transducer for use with:
ACUSON P500™ Ultrasound System Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
( Track1
Only)	Specific
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
	Ophthalmic
	Fetal	P	P	P		P	P	BMDC	Note 2, 3, 4, 11, 12, 16
	Abdominal
	Intra-operative
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric
	SmallOrgan
(Note 1)	P	P	P		P	P	BMDC	Note 2, 3, 4, 11, 12, 16
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	BMDC	Note 2, 3, 4, 11, 12, 16
	Trans-vaginal	P	P	P		P	P	BMDC	Note 2, 3, 4, 11, 12, 16
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
(Note 5)
	Other (Specify)

N = new indication; P = previously cleared K150050

Note 1	For example: breast, testes, thyroid, prostate, etc.
Note 2	Dynamic TCE Technology
Note 3	Advanced SieClear
Note 4	eSielmage
Note 5	For example: abdominal, vascular (upper and lower)
Note 6	Stress Echo
Note 7	eSieMeasure
Note 8	eSieScan
Note 9	AHP
Note 10	DTI
Note 11	Panoramic 2D Imaging (SieScape)
Note 12	Clarify VE
Note 13	Needle Visualization
Note 14	Intracardiac Echocardiography (ICE) Imaging
Note 15	CARTOSOUND Communication
Note 16	Probe Saver

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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78

510(k) Number (if known):
---------------------------

Device Name:

Intended Use:

VF13-5 Linear Transducer for use with:
ACUSON P500™ Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
(Track1
Only)	Specific
(Tracks1&3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric
	SmallOrgan
(Note 1)	P	P	P		P	P	BMDC	Note 2, 3, 4, 9, 11, 12, 13, 16
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)	P	P	P		P	P	BMDC	Note 2, 3, 4 , 9, 11, 12, 13, 16
	Intra-vascular
	Other
(Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
(Note 5)	P	P	P		P	P	BMDC	Note 2, 3, 4, 9, 11, 12, 13, 16
	Other (Specify)

N = new indication; P = previously cleared K150050

Note 1	For example: breast, testes, thyroid, prostate, etc.
Note 2	Dynamic TCE Technology
Note 3	Advanced SieClear
Note 4	eSielmage
Note 5	For example: abdominal, vascular (upper and lower)
Note 6	Stress Echo
Note 7	eSieMeasure
Note 8	eSieScan
Note 9	AHP
Note 10	DTI
Note 11	Panoramic 2D Imaging (SieScape)
Note 12	Clarify VE
Note 13	Needle Visualization
Note 14	Intracardiac Echocardiography (ICE) Imaging
Note 15	CARTOSOUND Communication
Note 16	Probe Saver

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Page 7 of 16

79

510(k) Number (if known):

VF16-5 Transducer for use with:
ACUSON P500™ Ultrasound System Device Name: Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
( Track1
Only)	Specific
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric
	SmallOrgan
(Note 1)	P	P	P		P	P	BMDC	Note 2, 3, 4, 9, 11, 12, 13, 16
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)	P	P	P		P	P	BMDC	Note 2, 3, 4, 9, 11, 12, 13, 16
	Intra-vascular
	Other
(Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
(Note 5)
	Other (Specify)

N = new indication; P = previously cleared K141846

Note 1	For example: breast, testes, thyroid, prostate, etc.
Note 2	Dynamic TCE Technology
Note 3	Advanced SieClear
Note 4	eSielmage
Note 5	For example: abdominal, vascular (upper and lower)
Note 6	Stress Echo
Note 7	eSieMeasure
Note 8	eSieScan
Note 9	AHP
Note 10	DTI
Note 11	Panoramic 2D Imaging (SieScape)
Note 12	Clarify VE
Note 13	Needle Visualization
Note 14	Intracardiac Echocardiography (ICE) Imaging
Note 15	CARTOSOUND Communication
Note 16	Probe Saver

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Page 8 of 16

80

510(k) Number (if known):

Device Name:

P8-4 Transducer for use with:
ACUSON P500™ Ultrasound System

Intended Use:

C-4 Transducer for use With:
CUSON P500™ Ultrasound System

Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
( Track1
Only)	Specific
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal
Imaging
& Other	Fetal
	Abdominal	P	P	P		P	P	BMDC	Note 2, 4, 12, 16
	Intra-operative
	Intra-operative
(Neuro)
	Laparoscopic
	Pediatric
	SmallOrgan
(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric	P	P	P	P	P	P	BMDC	Note 2, 4, 6, 7, 10, 12, 16
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
(Note 5)
	Other (Specify)

N = new indication; P = previously cleared by K141846, K161787

Note 1	For example: breast, testes, thyroid, prostate, etc.
Note 2	Dynamic TCE Technology
Note 3	Advanced SieClear
Note 4	eSielmage
Note 5	For example: abdominal, vascular (upper and lower)
Note 6	Stress Echo
Note 7	eSieMeasure
Note 8	eSieScan
Note 9	AHP
Note 10	DTI
Note 11	Panoramic 2D Imaging (SieScape)
Note 12	Clarify VE
Note 13	Needle Visualization
Note 14	Intracardiac Echocardiography (ICE) Imaging
Note 15	CARTOSOUND Communication
Note 16	Probe Saver

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Page 9 of 16

81

510(k) Number (if known):

Device Name:

0-5v Transducer for use with:

Intended Use:

L10-5v Transducer for use with:
ACUSON P500™ Ultrasound System

Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
( Track1
Only)	Specific
(Tracks11& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric
Imaging
& Other	SmallOrgan
(Note 1)	P	P	P		P	P	BMDC	Note 2, 3, 4, 9, 11, 12, 13, 16
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)	P	P	P		P	P	BMDC	Note 2, 3, 4, 9, 11, 12, 13, 16
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
(Note 5)	P	P	P		P	P	BMDC	Note 2, 3, 4, 9, 11, 12, 13, 16
Vessel	Other (Specify)

N = new indication; P = previously cleared K161787

Note 1	For example: breast, testes, thyroid, prostate, etc.
Note 2	Dynamic TCE Technology
Note 3	Advanced SieClear
Note 4	eSielmage
Note 5	For example: abdominal, vascular (upper and lower)
Note 6	Stress Echo
Note 7	eSieMeasure
Note 8	eSieScan
Note 9	AHP
Note 10	DTI
Note 11	Panoramic 2D Imaging (SieScape)
Note 12	Clarify VE
Note 13	Needle Visualization
Note 14	Intracardiac Echocardiography (ICE) Imaging
Note 15	CARTOSOUND Communication
Note 16	Probe Saver

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Page 10 of 16

82

510(k) Number (if known):

Device Name:

CW2 Transducer for use with:
ACUSON P500™ Ultrasound System

Intended Use:

Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
( Track1
Only)	Specific
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric
Imaging
& Other	SmallOrgan
(Note 1)
	Neonatal Cephalic				P
	Adult Cephalic				P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
	Cardiac Adult				P
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
(Note 5)				P
Vessel	Other (Specify)

N = new indication; P = previously cleared K141846

Note 1	For example: breast, testes, thyroid, prostate, etc.
Note 2	Dynamic TCE Technology
Note 3	Advanced SieClear
Note 4	eSielmage
Note 5	For example: abdominal, vascular (upper and lower)
Note 6	Stress Echo
Note 7	eSieMeasure
Note 8	eSieScan
Note 9	AHP
Note 10	DTI
Note 11	Panoramic 2D Imaging (SieScape)
Note 12	Clarify VE
Note 13	Needle Visualization
Note 14	Intracardiac Echocardiography (ICE) Imaging
Note 15	CARTOSOUND Communication
Note 16	Probe Saver

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Page 11 of 16

83

510(k) Number (if known):

Device Name:

CW5 Transducer for use with:
ACUSON P500™ Ultrasound System

Intended Use:

CUSON P500™ Ultrasound System

Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
( Track1
Only)	Specific
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric
Imaging
& Other	SmallOrgan
(Note 1)
	Neonatal Cephalic				P
	Adult Cephalic				P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
	Cardiac Adult				P
Cardiac	Cardiac Pediatric				P
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
(Note 5)				P
Vessel	Other (Specify)

N = new indication; P = previously cleared by K141846

Note 1	For example: breast, testes, thyroid, prostate, etc.
Note 2	Dynamic TCE Technology
Note 3	Advanced SieClear
Note 4	eSielmage
Note 5	For example: abdominal, vascular (upper and lower)
Note 6	Stress Echo
Note 7	eSieMeasure
Note 8	eSieScan
Note 9	AHP
Note 10	DTI
Note 11	Panoramic 2D Imaging (SieScape)
Note 12	Clarify VE
Note 13	Needle Visualization
Note 14	Intracardiac Echocardiography (ICE) Imaging
Note 15	CARTOSOUND Communication
Note 16	Probe Saver

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84

510(k) Number (if known):

510(k) Number (if known):
Device Name:		AcuNav 8F Transducer for use with:
ACUSON P500™ Diagnostic Ultrasound System
Intended Use:		Diagnostic imaging or fluid flow analysis of the human body as follows:
Clinical Application			Mode of Operation
Other
( Track1
Only)	Specific
(Tracks11& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric
	SmallOrgan
(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac	P	P	P	P	P	P	BMDC	Note 2, 4, 10, 12, 14, 16
	Other (Specify)
	Peripheral vessel

Other (Specify) N = new indication; P = previously cleared K141846

(Note 5)

Note 1	For example: breast, testes, thyroid, prostate, etc.
Note 2	Dynamic TCE Technology
Note 3	Advanced SieClear
Note 4	eSielmage
Note 5	For example: abdominal, vascular (upper and lower)
Note 6	Stress Echo
Note 7	eSieMeasure
Note 8	eSieScan
Note 9	AHP
Note 10	DTI
Note 11	Panoramic 2D Imaging (SieScape)
Note 12	Clarify VE
Note 13	Needle Visualization
Note 14	Intracardiac Echocardiography (ICE) Imaging
Note 15	CARTOSOUND Communication
Note 16	Probe Saver

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Peripheral

Vessel

Page 13 of 16

85

510(k) Number (if known):

AcuNav 10F Transducer for use with:
ACUSON P500™ Diagnostic Ultrasound System Device Name: Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation Other Specific Color Power Combined Other B M PWD CWD ( Track1 (Tracks1I& 3) Doppler Doppler (Specify) (Specify) Only) Ophthalmic Ophthalmic Fetal Abdominal Intra-operative Intra-operative (Neuro) Laparoscopic Fetal Pediatric Imaging SmallOrgan & Other (Note 1) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.)

Other (Specify) N = new indication; P = previously cleared K141846

Other (Specify) Peripheral vessel

(Note 5)

Cardiac Pediatric Intra-vascular (Cardiac) Trans-esophageal (Cardiac) Intra-cardiac

Musculo-skel. (Convent.) Musculo-skel. (Superfic) Intra-vascular Other (Specify) Cardiac Adult

Note 1	For example: breast, testes, thyroid, prostate, etc.
Note 2	Dynamic TCE Technology
Note 3	Advanced SieClear
Note 4	eSielmage
Note 5	For example: abdominal, vascular (upper and lower)
Note 6	Stress Echo
Note 7	eSieMeasure
Note 8	eSieScan
Note 9	AHP
Note 10	DTI
Note 11	Panoramic 2D Imaging (SieScape)
Note 12	Clarify VE
Note 13	Needle Visualization
Note 14	Intracardiac Echocardiography (ICE) Imaging
Note 15	CARTOSOUND Communication
Note 16	Probe Saver

b

b

BMDC

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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b

b

b

b

• 510(k)_
  Cardiac

Peripheral

Vessel

Note 2, 4, 10, 12, 14, 16

86

510(k) Number (if known):

Soundstar 10F Transducer for use with:
ACUSON P500™ Diagnostic Ultrasound System Device Name: Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation Other Specific Color Power Combined

| Other
( Track1
Only) | Specific
(Tracks1 & 3) | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Combined
(Specify) | Other
(Specify) |
|----------------------------|-------------------------------|---|---|-----|-----|------------------|------------------|-----------------------|-------------------------------|
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative | | | | | | | | |
| | Intra-operative
(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal | Pediatric | | | | | | | | |
| Imaging
& Other | SmallOrgan
(Note 1) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.
(non-Card.) | | | | | | | | |
| | Musculo-skel.
(Convent.) | | | | | | | | |
| | Musculo-skel.
(Superfic) | | | | | | | | |
| | Intra-vascular | | | | | | | | |
| | Other
(Specify) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Intra-vascular
(Cardiac) | | | | | | | | |
| | Trans-esophageal
(Cardiac) | | | | | | | | |
| | Intra-cardiac | P | P | P | P | P | P | BMDC | Note 2, 4, 10, 12, 14, 15, 16 |
| | Other (Specify) | | | | | | | | |
| Peripheral | Peripheral vessel
(Note 5) | | | | | | | | |
| Vessel | Other (Specify) | | | | | | | | |

N = new indication; P = previously cleared K141846

Note 1	For example: breast, testes, thyroid, prostate, etc.
Note 2	Dynamic TCE Technology
Note 3	Advanced SieClear
Note 4	eSielmage
Note 5	For example: abdominal, vascular (upper and lower)
Note 6	Stress Echo
Note 7	eSieMeasure
Note 8	eSieScan
Note 9	AHP
Note 10	DTI
Note 11	Panoramic 2D Imaging (SieScape)
Note 12	Clarify VE
Note 13	Needle Visualization
Note 14	Intracardiac Echocardiography (ICE) Imaging
Note 15	CARTOSOUND Communication
Note 16	Probe Saver

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87

510(k) Number (if known): Soundstar eco 8F Transducer for use with:
ACUSON P500™ Diagnostic Ultrasound System Device Name: Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation Other Specific Color Power Combined Other B M PWD CWD ( Track1 (Tracks1I& 3) Doppler Doppler (Specify) (Specify) Only) Ophthalmic Ophthalmic Fetal Abdominal Intra-operative Intra-operative (Neuro) Laparoscopic Fetal Pediatric Imaging SmallOrgan & Other (Note 1) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skel. (Convent.) Musculo-skel. (Superfic) Intra-vascular Other (Specify) Cardiac Adult Cardiac Cardiac Pediatric Intra-vascular (Cardiac) Trans-esophageal (Cardiac) Intra-cardiac b b b b b b BMDC Note 2, 4, 10, 12, 14, 15, 16 Other (Specify) Peripheral vessel Peripheral (Note 5) Vessel Other (Specify)

N = new indication; P = previously cleared K141846

Note 1	For example: breast, testes, thyroid, prostate, etc.
Note 2	Dynamic TCE Technology
Note 3	Advanced SieClear
Note 4	eSielmage
Note 5	For example: abdominal, vascular (upper and lower)
Note 6	Stress Echo
Note 7	eSieMeasure
Note 8	eSieScan
Note 9	AHP
Note 10	DTI
Note 11	Panoramic 2D Imaging (SieScape)
Note 12	Clarify VE
Note 13	Needle Visualization
Note 14	Intracardiac Echocardiography (ICE) Imaging
Note 15	CARTOSOUND Communication
Note 16	Probe Saver

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88

510(k) Number (if known):

Soundstar eco 10F Transducer for use with: Device Name: ACUSON P500™ Diagnostic Ultrasound System Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation Other Specific Color Power Combined Other B M PWD CWD ( Track1 (Tracks1I& 3) Doppler Doppler (Specify) (Specify) Only) Ophthalmic Ophthalmic Fetal Abdominal Intra-operative Intra-operative (Neuro) Laparoscopic Fetal Pediatric Imaging SmallOrgan & Other (Note 1) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skel. (Convent.) Musculo-skel. (Superfic) Intra-vascular Other (Specify) Cardiac Adult Cardiac Cardiac Pediatric Intra-vascular (Cardiac) Trans-esophageal (Cardiac) Intra-cardiac b b b b b b BMDC Note 2, 4, 10, 12, 14, 15, 16 Other (Specify) Peripheral vessel Peripheral (Note 5) Vessel Other (Specify)

N = new indication; P = previously cleared K141846

Note 1	For example: breast, testes, thyroid, prostate, etc.
Note 2	Dynamic TCE Technology
Note 3	Advanced SieClear
Note 4	eSielmage
Note 5	For example: abdominal, vascular (upper and lower)
Note 6	Stress Echo
Note 7	eSieMeasure
Note 8	eSieScan
Note 9	AHP
Note 10	DTI
Note 11	Panoramic 2D Imaging (SieScape)
Note 12	Clarify VE
Note 13	Needle Visualization
Note 14	Intracardiac Echocardiography (ICE) Imaging
Note 15	CARTOSOUND Communication
Note 16	Probe Saver

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Indications for Use

510(k) Number (if known) K202683

Device Name

ACUSON NX3 Diagnostic Ultrasound System ACUSON NX3 Elite Diagnostic Ultrasound System

Indications for Use (Describe)

For ACUSON NX3

The ACUSON NX3 ultrasound imaging system is intended for the following applications: Fetal Abdominal (including liver), Pediatric, Small Parts (Small Organ), Neonatal Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular (including Peripheral Vessel), Musculoskeletal and Urology applications.

The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

For ACUSON NX3 Elite

The ACUSON NX3 Elite ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Organ including intra-operative), Neonatal Cephalic, Adult Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac(including Transesophageal), Vascular (including Peripheral Vessel, intra-operative), Musculoskeletal, Superficial Musculoskeletal and Urology applications.

The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system.

Note: This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Medicine."

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

90

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

91

510(k) Number (if known):

Device Name: Intended Use: ACUSON NX3 Elite™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | | | Other
(Specify) |
|---------------------------|---------------------------------------------------------|-------------------|---|-----|-----|------------------|------------------|----------------------|--------------------|--------------------|
| Other
(Track1
Only) | Specific
(Tracks1& 3) | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Combined
(Note 3) | Other
(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | P | P | P | | P | P | P | | |
| | Abdominal | P | P | P | | P | P | P | | |
| | Intra-operative
(Note 2) | P | P | P | | P | P | P | | |
| | Intra-operative
(Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| Fetal | Pediatric | P | P | P | | P | P | P | | |
| Imaging
& Other | SmallOrgan
(Note 1) | P | P | P | | P | P | P | | |
| | Neonatal Cephalic | P | P | P | | P | P | P | | |
| | Adult Cephalic | P | P | P | P | P | P | P | | |
| | Trans-rectal | P | P | P | | P | P | P | | |
| | Trans-vaginal | P | P | P | | P | P | P | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.
(non-Card.) | | | | | | | | | |
| | Musculo-skel.
(Convent.) | P | P | P | | P | P | P | | |
| | Musculo-skel.
(Superfic) | P | P | P | | P | P | P | | |
| | Intra -vascular | | | | | | | | | |
| | Other
(Specify) | | | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | P | | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P | | |
| | Intra-vascular
(Cardiac) | | | | | | | | | |
| | Trans-esophageal
(Cardiac) | P | P | P | P | P | P | P | | |
| | Intra-Cardiac | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | | P | P | P | | |
| Vessel | Other (Specify) | | | | | | | | | |
| | N = new indication; P = previously cleared by (K173957) | | | | | | | | | |

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: abdominal, vascular

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

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92

510(k) Number (if known):

Device Name: Intended Use: ACUSON NX3TM Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
( Track1
Only)	Specific
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Note 3)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal	P	P	P		P	P	P
	Intra-operative
(Note 2)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric	P	P	P		P	P	P
Imaging
& Other	SmallOrgan
(Note 1)	P	P	P		P	P	P
	Neonatal Cephalic	P	P	P		P	P	P
	Adult Cephalic	P	P	P		P	P	P
	Trans-rectal	P	P	P		P	P	P
	Trans-vaginal	P	P	P		P	P	P
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)	P	P	P		P	P	P
	Musculo-skel.
(Superfic)	P	P	P		P	P	P
	Intra -vascular
	Other
(Specify)
	Cardiac Adult	P	P	P		P	P	P
Cardiac	Cardiac Pediatric	P	P	P		P	P	P
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-Cardiac
	Other (Specify)
Peripheral	Peripheral vessel	P	P	P		P	P	P
Vessel	Other (Specify)

N = new indication; P = previously cleared by (K173957)

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

Note 2 For example: abdominal, vascular

Note 3 Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M

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93

510(k) Number (if known):

| Device Name: | | CH5-2 Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound
System | | | | | | | | | |
|-----------------------------|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------|-----|-----|------------------|------------------|-------------------------------------------------------------------------|--------------------|--|--|
| Intended Use: | | | | | | | | Diagnostic imaging or fluid flow analysis of the human body as follows: | | | |
| Clinical Application | | | Mode of Operation | | | | | | | | |
| Other
( Track 1
Only) | Specific
(Tracks11& 3) | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Combined
(Note 3) | Other
(Specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal | P | P | P | | P | P | P | | | |
| | Abdominal | P | P | P | | P | P | P | | | |
| | Intra-operative
(Note 2) | | | | | | | | | | |
| | Intra-operative
(Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| Fetal | Pediatric | P | P | P | | P | P | P | | | |
| Imaging
& Other | SmallOrgan
(Note 1) | | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph.
(non-Card.) | | | | | | | | | | |
| | Musculo-skel.
(Convent.) | | | | | | | | | | |
| | Musculo-skel.
(Superfic) | | | | | | | | | | |
| | Intra-vascular | | | | | | | | | | |
| | Other
(Specify) | | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | | |
| | Intra-vascular | | | | | | | | | | |
| | (Cardiac) | | | | | | | | | | |
| | Trans-esophageal
(Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | | P | P | P | | | |
| Vessel | Other (Specify) | | | | | | | | | | |

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: abdominal, vascular

Note 3 Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M

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94

510(k) Number (if known):

Device Name:

VF10-5 Linear Array Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound System

Intended Use:

Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
( Track 1
Only)	Specific
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Note 3)	Other
(Specify)
	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P
	Intra-operative
(Note 2)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric	P	P	P		P	P	P
Imaging
& Other	SmallOrgan
(Note 1)	P	P	P		P	P	P
	Neonatal Cephalic
	Adult Cephalic	P	P	P		P	P	P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)	P	P	P		P	P	P
	Musculo-skel.
(Superfic)	P	P	P		P	P	P
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	P
Peripheral
Vessel	Other (Specify)

N = new indication; P = previously cleared by (K173957)

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: abdominal, vascular

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

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95

510(k) Number (if known):

Device Name:

VF12-4 Linear Array Transducer for use with:

VF12-4 Linear Array Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound System

Intended Use:

Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
( Track1
Only)	Specific
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Note 3)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P
	Intra-operative
(Note 2)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	P	P	P		P	P	P
	SmallOrgan
(Note 1)	P	P	P		P	P	P
	Neonatal Cephalic

• NX3 Elite only | P | P | P | | P | P | P | |
  | | Adult Cephalic | P | P | P | | P | P | P | |
  | | Trans-rectal | | | | | | | | |
  | | Trans-vaginal | | | | | | | | |
  | | Trans-urethral | | | | | | | | |
  | | Trans-esoph.
  (non-Card.) | | | | | | | | |
  | | Musculo-skel.
  (Convent.) | P | P | P | | P | P | P | |
  | | Musculo-skel.
  (Superfic) | P | P | P | | P | P | P | |
  | | Intra-vascular | | | | | | | | |
  | | Other
  (Specify) | | | | | | | | |
  | Cardiac | Cardiac Adult | | | | | | | | |
  | | Cardiac Pediatric | | | | | | | | |
  | | Intra-vascular
  (Cardiac) | | | | | | | | |
  | | Trans-esophageal
  (Cardiac) | | | | | | | | |
  | | Intra-cardiac | | | | | | | | |
  | | Other (Specify) | | | | | | | | |
  | Peripheral
  Vessel | Peripheral vessel | P | P | P | | P | P | P | |
  | | Other (Specify) | | | | | | | | |
  | N = new indication; P = previously cleared by (K173957) | | | | | | | | | |

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: abdominal, vascular

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

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96

510(k) Number (if known):

Device Name: Intended Use:

EC10-5w Convex Array Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System

Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
(Track1
Only)	Specific
(Tracks 1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Note 3)	Other
(Specify)
Ophthalmic	Ophthalmic	P	P	P		P	P	P
	Fetal	P	P	P		P	P	P
	Abdominal
	Intra-operative
(Note 2)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric
	SmallOrgan
(Note 1)	P	P	P		P	P	P
	Neonatal Cephalic	P	P	P		P	P	P
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P
	Trans-vaginal	P	P	P		P	P	P
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-Cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared by (K173957)

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: abdominal, vascular

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

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97

510(k) Number (if known):

Device Name:

EC9-4 Convex Array Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound System

Intended Use:

Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
(Track1
Only)	Specific
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Note 3)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal
	Intra-operative
(Note 2)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric
SmallOrgan
(Note 1)	P	P	P		P	P	P
	Neonatal Cephalic

• NX3 Elite Only | P | P | P | | P | P | P | |
  | | Adult Cephalic | | | | | | | | |
  | | Trans-rectal | P | P | P | | P | P | P | |
  | | Trans-vaginal | P | P | P | | P | P | P | |
  | | Trans-urethral | | | | | | | | |
  | | Trans-esoph.
  (non-Card.) | | | | | | | | |
  | | Musculo-skel.
  (Convent.) | | | | | | | | |
  | | Musculo-skel.
  (Superfic) | | | | | | | | |
  | | Intra-vascular | | | | | | | | |
  | | Other
  (Specify) | | | | | | | | |
  | | Cardiac Adult | | | | | | | | |
  | Cardiac | Cardiac Pediatric | | | | | | | | |
  | | Intra-vascular
  (Cardiac) | | | | | | | | |
  | | Trans-esophageal
  (Cardiac) | | | | | | | | |
  | | Intra-Cardiac | | | | | | | | |
  | | Other (Specify) | | | | | | | | |
  | Peripheral
  Vessel | Peripheral vessel | | | | | | | | |
  | | Other (Specify) | | | | | | | | |

N = new indication; P = previously cleared by (K173957)

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: abdominal, vascular Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

E 3 Combined modes are D/W, D/C, D/I WD, D/I Power, D/CI WD or C/WD, D/CI/M

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98

510(k) Number (if known):

CW2 Continuous Wave Doppler Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System

Device Name: Intended Use:

Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
(Track1
Only)	Specific
(Tracks1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Note 3)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
(Note 2)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric
	SmallOrgan
(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
Cardiac	Cardiac Adult				P
	Cardiac Pediatric				P
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)
	N = new indication; P = previously cleared by (K173957)

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: abdominal, vascular

Note 3 Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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99

510(k) Number (if known):

CW5 Continuous Wave Doppler Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System

Device Name: Intended Use:

Diagnostic imaging or fluid flow analysis of the human body as follows:

| Clinical Application | Other
(Track1
Only) | Specific
(Tracks1 & 3) | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Combined
(Note 3) | Other
(Specify) |
|---------------------------------------------------------|-----------------------------|-------------------------------|---|---|-----|-----|------------------|------------------|----------------------|--------------------|
| Ophthalmic | | Ophthalmic | | | | | | | | |
| Fetal
Imaging
& Other | | Fetal | | | | | | | | |
| | | Abdominal | | | | | | | | |
| | | Intra-operative
(Note 2) | | | | | | | | |
| | | Intra-operative
(Neuro) | | | | | | | | |
| | | Laparoscopic | | | | | | | | |
| | | Pediatric | | | | | | | | |
| | | SmallOrgan
(Note 1) | | | | | | | | |
| | | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | P | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.
(non-Card.) | | | | | | | | | |
| | Musculo-skel.
(Convent.) | | | | | | | | | |
| | Musculo-skel.
(Superfic) | | | | | | | | | |
| | Intra-vascular | | | | | | | | | |
| | Other
(Specify) | | | | | | | | | |
| Cardiac | | Cardiac Adult | | | | P | | | | |
| | | Cardiac Pediatric | | | | P | | | | |
| | | Intra-vascular
(Cardiac) | | | | | | | | |
| | | Trans-esophageal
(Cardiac) | | | | | | | | |
| | | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| Peripheral
Vessel | | Peripheral vessel | | | | | | | | |
| | | Other (Specify) | | | | | | | | |
| N = new indication; P = previously cleared by (K173957) | | | | | | | | | | |

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: abdominal, vascular

Note 3 Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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100

510(k) Number (if known):

Device Name:

P4-2 Phased Sector Array Transducer for use with:

P4-2 Phased Sector Array Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound System

Intended Use:

Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
( Track 1
Only)	Specific
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Note 3)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal	P	P	P		P	P	P
	Intra-operative
(Note 2)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric	P	P	P		P	P	P
Imaging
& Other	SmallOrgan
(Note 1)	P	P	P		P	P	P
	Neonatal Cephalic
– NX3 Elite Only	P	P	P		P	P	P
	Adult Cephalic	P	P	P		P	P	P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
	Cardiac Adult	P	P	P	P	P	P	P
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)
		N = new indication; P = previously cleared by (K173957)

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: abdominal, vascular Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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101

510(k) Number (if known):

VF16-5 Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System

Device Name:

Diagnostic imaging or fluid flow analysis of the human body as follows:

Intended Use:

Clinical Application		Mode of Operation
Other
(Track1
Only)	Specific
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Note 3)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P
	Intra-operative
(Note 2)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	P	P	P		P	P	P
	SmallOrgan
(Note 1)	P	P	P		P	P	P
	Neonatal Cephalic
	Adult Cephalic	P	P	P		P	P	P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)	P	P	P		P	P	P
	Musculo-skel.
(Superfic)	P	P	P		P	P	P
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared by (K173957)

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: abdominal, vascular

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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102

510(k) Number (if known):

VF13-5sp Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System

Device Name:

Diagnostic imaging or fluid flow analysis of the human body as follows:

Intended Use:

Clinical Application		Mode of Operation
Other
(Track1
Only)	Specific
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Note 3)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
(Note 2)	P	P	P		P	P	P
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric	P	P	P		P	P	P
Imaging
& Other	SmallOrgan
(Note 1)	P	P	P		P	P	P
	Neonatal Cephalic
	Adult Cephalic	P	P	P		P	P	P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)	P	P	P		P	P	P
	Musculo-skel.
(Superfic)	P	P	P		P	P	P
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
(Note 1)	P	P	P		P	P	P
Vessel	Other (Specify)

N = new indication; P = previously cleared by (K173957)

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: abdominal, vascular, small parts

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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103

510(k) Number (if known):

| Device Name: | | C8F3 Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound System | | | | | | | |
|-----------------------------|-------------------------------|----------------------------------------------------------------------------------------------------------------------------|---|-----|-----|------------------|------------------|----------------------|--------------------|
| Intended Use: | | Diagnostic imaging or fluid flow analysis of the human body as follows: | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | | |
| Other
( Track1
Only) | Specific
(Tracks1& 3) | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Combined
(Note 3) | Other
(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | P | |
| | Abdominal | P | P | P | | P | P | P | |
| | Intra-operative
(Note 2) | | | | | | | | |
| | Intra-operative
(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal
Imaging
& Other | Pediatric | | | | | | | | |
| | SmallOrgan
(Note 1) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.
(non-Card.) | | | | | | | | |
| | Musculo-skel.
(Convent.) | | | | | | | | |
| | Musculo-skel.
(Superfic) | | | | | | | | |
| | Intra-vascular | | | | | | | | |
| | Other
(Specify) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Intra-vascular
(Cardiac) | | | | | | | | |
| | Trans-esophageal
(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| | Peripheral vessel | | | | | | | | |
| Peripheral
Vessel | Other (Specify) | | | | | | | | |

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: abdominal, vascular

Note 3 Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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104

510(k) Number (if known):

C8-5 Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System

Device Name: Intended Use:

Diagnostic imaging or fluid flow analysis of the human body as follows:

HETEROCYCLES

Clinical Application		Mode of Operation
Other
( Track 1
Only)	Specific
(Tracks11& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Note 3)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P
	Intra-operative
(Note 2)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	P	P	P		P	P	P
	SmallOrgan
(Note 1)
	Neonatal Cephalic	P	P	P		P	P	P
	Adult Cephalic	P	P	P		P	P	P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric	P	P	P		P	P	P
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared by (K173957)

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: abdominal, vascular

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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105

510(k) Number (if known):

P8-4 Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System

Device Name:

Diagnostic imaging or fluid flow analysis of the human body as follows:

Intended Use:

Clinical Application		Mode of Operation
Other
(Track1
Only)	Specific
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Note 3)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	P
	Intra-operative
(Note 2)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	P	P	P	P	P	P	P
	SmallOrgan
(Note 1)
	Neonatal Cephalic	P	P	P	P	P	P	P
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared by (K173957)

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: abdominal, vascular

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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106

510(k) Number (if known):

11L4 Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3TM Diagnostic Ultrasound System

Device Name: Intended Use:

Diagnostic imaging or fluid flow analysis of the human body as follows:

| Clinical Application | Other
( Track1
Only) | Specific
(Tracks1I&3) | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Combined
(Note 3) | Other
(Specify) |
|-----------------------------|----------------------------|-------------------------------|-------------------|---|-----|-----|------------------|------------------|----------------------|--------------------|
| Ophthalmic | | Ophthalmic | | | | | | | | |
| Fetal
Imaging
& Other | | Fetal | | | | | | | | |
| | | Abdominal | P | P | P | | P | P | P | |
| | | Intra-operative
(Note 2) | | | | | | | | |
| | | Intra-operative
(Neuro) | | | | | | | | |
| | | Laparoscopic | | | | | | | | |
| | | Pediatric | P | P | P | | P | P | P | |
| | | SmallOrgan
(Note 1) | P | P | P | | P | P | P | |
| | | Neonatal Cephalic | | | | | | | | |
| | | Adult Cephalic | P | P | P | | P | P | P | |
| | | Trans-rectal | | | | | | | | |
| | | Trans-vaginal | | | | | | | | |
| | | Trans-urethral | | | | | | | | |
| | | Trans-esoph.
(non-Card.) | | | | | | | | |
| | | Musculo-skel.
(Convent.) | P | P | P | | P | P | P | |
| | | Musculo-skel.
(Superfic) | P | P | P | | P | P | P | |
| | | Intra-vascular | | | | | | | | |
| | | Other
(Specify) | | | | | | | | |
| | Cardiac | | Cardiac Adult | | | | | | | |
| | | | Cardiac Pediatric | | | | | | | |
| | | Intra-vascular
(Cardiac) | | | | | | | | |
| | | Trans-esophageal
(Cardiac) | | | | | | | | |
| | | Intra-cardiac | | | | | | | | |
| | | Other (Specify) | | | | | | | | |
| Peripheral
Vessel | | Peripheral vessel | P | P | P | | P | P | P | |
| | | Other (Specify) | | | | | | | | |

N = new indication; P = previously cleared by (K173957)

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: abdominal, vascular

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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107

510(k) Number (if known):

10MC3 Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3TM Diagnostic Ultrasound System

Device Name: Intended Use:

Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
( Track 1
Only)	Specific
(Tracks11& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Note 3)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P
	Abdominal
	Intra-operative
(Note 2)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric
Imaging
& Other	SmallOrgan
(Note 1)	P	P	P	P	P	P	P
	Neonatal Cephalic	P	P	P	P	P	P	P
	Adult Cephalic
	Trans-rectal	P	P	P	P	P	P	P
	Trans-vaginal	P	P	P	P	P	P	P
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared by (K173957)

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: abdominal, vascular

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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108

510(k) Number (if known):

BP10-3 Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound System

Device Name: Intended Use:

Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
( Track 1
Only)	Specific
(Tracks1I&3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Note 3)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
(Note 2)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric
Imaging
& Other	SmallOrgan
(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared by (K173957)

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: abdominal, vascular

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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109

510(k) Number (if known):

V5Ms Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System Device Name: Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation Other Specific
(Tracks1I& 3) Color Power Combined
(Note 3) Other (Track1 B M PWD CWD Doppler Doppler (Specify) Only) Ophthalmic Ophthalmic Fetal Abdominal Intra-operative (Note 2) Intra-operative (Neuro) Laparoscopic Fetal Pediatric SmallOrgan Imaging & Other (Note 1) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skel. (Convent.) Musculo-skel. (Superfic) Intra-vascular Other (Specify) Cardiac Adult Cardiac Cardiac Pediatric Intra-vascular (Cardiac) Trans-esophageal P P P P P P b (Cardiac) Intra-cardiac Other (Specify) Peripheral Peripheral vessel Vessel Other (Specify)

N = new indication; P = previously cleared by (K173957)

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 For example: abdominal, vascular

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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510(k) Summary

This summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21CFR §807.92(c)

Date prepared:	September 11, 2020 – Date Updated: Oct. 13, 2020
Part 1. Sponsor:	Siemens Medical Solutions USA, Inc.,
Ultrasound Division
	22010 South East 51st Street
Issaquah, WA 98029, USA
Contact Person:	Christine Dunbar
	Senior Regulatory Affairs
	Siemens Medical Solutions USA, Inc.,
Ultrasound Division
	685 East Middlefield Road
	Mountain View, California 94043
	Email: [e-mail]
	Tel: [phone]
Part 2. Device
Name:	ACUSON Sequoia Diagnostic Ultrasound System
ACUSON SC2000 Diagnostic Ultrasound System
ACUSON Freestyle Diagnostic Ultrasound System
ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems
ACUSON P200 Diagnostic Ultrasound System
ACUSON P500 Diagnostic Ultrasound System
ACUSON NX3, NX3 Elite Diagnostic Ultrasound System
Common Name:	Diagnostic ultrasound system and transducers
Classification
Name:	Ultrasonic Pulsed Doppler Imaging System, Ultrasonic Pulsed Echo Imaging System, Diagnostic Ultrasound Transducer, Diagnostic Intravascular Catheter, Picture Archiving and Communications System, Biopsy Needle Guide Kit
Classification:	Regulatory Class: II
Review Category: Tier II
Classification Panel	Radiology and Cardiology
CFR Section	21 CFR §892.1550, §892.1560, §892.1570, §870.1200,
§892.2050, §892.1560.
Product Code	90-ΙΥΝ, 90-IYO, 90-ITX, 90-OBJ, 90-LLZ, 90-OIJ

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Legal Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Division 22010 South East 51st Street Issaquah, WA 98029, USA

Part 3. Legally Marketed Predicate Devices

The Siemens ACUSON Diagnostic Ultrasound systems as described in this Special 510(k) submission is substantially equivalent to the company's legally marketed devices as represented below:

| Primary Predicate Device

Name	510(k) Clearance # / Date	Product Code
ACUSON Sequoia	K201462 / June 24th, 2020	IYN, IYO, ITX, OIJ
ACUSON SC2000	K200585 / April 22, 2020	IYN, IYO, ITX, OBJ, LLZ
ACUSON Freestyle	K200644 / April 10, 2020	IYN, IYO, OIJ, ITX
ACUSON S1000, S2000,
S3000	K172162 / Aug. 16, 2017	IYN, IYO, ITX, OBJ
ACUSON P200	K191922 / Aug. 15, 2019	IYN, IYO, ITX
ACUSON P500	K163396 / Jan. 04, 2017	IYN, IYO, ITX, OBJ
ACUSON NX3, NX3 Elite	K192835 / Oct. 22, 2019	IYN, IYO, ITX
Secondary Predicate
Device Name
ACUSON Juniper	K201130 / May 26, 2020	IYN, IYO, ITX, OIJ
Reference Predicate
Philips Affiniti™ Diagnostic
Ultrasound System Series	K201012 / May 1, 2020	IYN, IYO, ITX, QIH

Part 4. Device Description for Representative Device, ACUSON Sequoia:

The ACUSON Sequoia Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes,

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Panoramic Imaging, Contrast agent Imaging, Virtual Touch Strain Imaging, Virtual Touch - pSWE Imaging, Virtual Touch - SWE Imaging, syngo Velocity Vector Imaging, Custom Tissue Imaging, 3D/4D Volume Imaging and Harmonic Imaging on a Display.

All of the transducers and the catheter-based transducers will follow Track 3 acoustic labeling (AIUM 1004, IEC 2007, AIUM/NEMA 2004a) and remain unchanged from the currently cleared ACUSON systems.

Note: Some ACUSON Diagnostic Ultrasound configurations of components, accessories and/or software may vary from device brands and within device families. There are no modifications, additions or labeling changes to components, accessories and/or software for each device indicated.

The ACUSON Diagnostic Ultrasound systems are intended to be used by trained medical professionals at various locations where patient care, evaluation, monitoring or research is performed.

Part 5. Intended Use and Indications for Use Statements:

K202683

ACUSON Sequoia Diagnostic Ultrasound System

Indications for Use:

The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

K202683

ACUSON SC2000 Diagnostic Ultrasound System

Indications for Use:

The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The typical examinations performed using the SC2000 Ultrasound System are:

Cardiac Imaging Applications and Analysis

The system transmits ultrasound energy into adult, pediatric, neonatal, and fetal cardiac patients creating 2D (B), 3D, MMode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the

Siemens Medical Solutions USA. Inc. Ultrasound Division

113

heail, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

The system also supports catheters which are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Vascular Imaging Applications and Analysis

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck; superficial and deep veins and arteries in the arms and legs and abdomen; and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic

capture of ultrasound images. The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Superficial Imaging Applications

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

Intraoperative Imaging Applications

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during intraoperative procedures. Transcranial Imaging Applications

The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence or absence of pathology. The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

K202683

ACUSON Freestyle Diagnostic Ultrasound System

Indications for Use:

The ACUSON Freestyle Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body performed by an appropriately trained healthcare professional in a healthcare setting for the following conditions:

Abdominal, Pediatric, Small Organ, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal (Superficial).

K202683

ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems Indications for Use: Siemens Medical Solutions USA, Inc.

Ultrasound Division

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The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN (including monitoring of the ovarian follicle development), Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, transesophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculoskeletal (superficial) and neonatal cardiac } and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task force, Endorsed by the Society for Vascular Imaging".

The ACUSON AcuNav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heard of adult and pediatric patients.

K202683

ACUSON P200 Diagnostic Ultrasound System

Indications for Use:

The ACUSON P200 ultrasound imaging system is intended for the following applications: Fetal, Abdominal, Pediatric, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Adult, Pediatric and Neonatal Cardiac, Pelvic, Neonatal Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures; fetal, abdominal, pediatric, small organ, neonatal cephalic, cardiac (adult, pediatric and neonatal), transesophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculoskeletal (superficial) and calculations packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

K202683

ACUSON P500 Ultrasound System

Indications for Use:

The ACUSON P500 ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver), Pediatric, Small parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Pelvic, Neonatal, Cardiac, IntraCardiac, Vascular (including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal, and Urology applications.

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The system also provides the ability to measure anatomical structures fetal, abdominal, small organ, transrectal, transvaginal, cardiovascular, peripheral vessel, musculoskeletal (conventional), and musculoskeletal (superficial) and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system.

This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography: Carotid Intima-Media Thickness Task force, Endorsed by the Society for Vascular Imaging". The ACUSON Acunav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

K202683

ACUSON NX3 Diagnostic Ultrasound System

ACUSON NX3 Elite Diagnostic Ultrasound System

Indications for Use:

For ACUSON NX3

The ACUSON NX3 ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Organ), Neonatal Cephalic, Adult Cephalic. Transcranial. OB/GYN. Pelvic. Neonatal. Cardiac. Vascular (including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. For ACUSON NX3 Elite

The ACUSON NX3 Elite ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Parts (Small Organ including intra-operative), Neonatal Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac (including Transesophageal), Vascular (including Peripheral Vessel, intra-operative), Musculoskeletal, Superficial Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system.

Note: This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography: Carotid Intima-Media Thickness Task force, Endorsed by the Society for Vascular Medicine".

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Part 6. Technological Characteristics as compared to Predicate Device

The subject devices are substantially equivalent to the cleared primary predicate devices and employs the same fundamental scientific technology and intended use/indications for use. The Intended Use and Indications for Use are not specifically intended to be modified, however the labeling is expanded to include Lung ultrasound imaging by use of marketing materials, training materials, references to clinical literature and instructions for the user to enable the creation of ultrasound protocols called Presets.

User labeling for the subject devices have been expanded to include information about lung ultrasound imaging, based on established methods or the latest professional society guidelines, for patients with coronavirus disease 2019 (COVID-19).

A comparison table as Table 2 is provided beginning on the following page:

	ACUSON Sequoia Diagnostic Ultrasound System K# Pending (Subject Device)	ACUSON Sequoia Diagnostic Ultrasound System K201462 (Predicate Device)	Comparison
Standard Feature
Indications for Use	The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and	The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and	Identical
Standard
Feature	ACUSON Sequoia
Diagnostic Ultrasound
System
K# Pending
(Subject Device)	ACUSON Sequoia
Diagnostic Ultrasound
System
K201462
(Predicate Device)	Comparison
	Peripheral Vascular
applications.	Peripheral Vascular
applications.
	The system also provides
the ability to measure
anatomical structures for
fetal, abdominal,
pediatric, small organ,
cardiac, transrectal,
transvaginal, peripheral
vessel, musculoskeletal
and calculation packages
that provide information
to the clinician that may
be used adjunctively with
other medical data
obtained by a physician
for clinical diagnosis
purposes.	The system also provides
the ability to measure
anatomical structures for
fetal, abdominal,
pediatric, small organ,
cardiac, transrectal,
transvaginal, peripheral
vessel, musculoskeletal
and calculation packages
that provide information
to the clinician that may
be used adjunctively with
other medical data
obtained by a physician
for clinical diagnosis
purposes.
Reusable?	Yes	Yes	Identical
Duration of Use	Limited (≤ 24 hours)	Limited (≤ 24 hours)	Identical
Scientific
Technology	Ultrasound Imaging	Ultrasound Imaging	Identical
Operating
principles	Diagnostic ultrasound
uses high-frequency
(above the audible range)
sound waves to
produce an image of
anatomical structures
within the body. Electrical
pulses vibrate
ceramics within a
transducer to transmit the
sound waves into the
body. Sound waves
travel through body tissue
at approximately 1,540
meters per second and
reflect back as
echoes to the transducer at	Diagnostic ultrasound
uses high-frequency
(above the audible range)
sound waves to
produce an image of
anatomical structures
within the body. Electrical
pulses vibrate
ceramics within a
transducer to transmit the
sound waves into the
body. Sound waves
travel through body tissue
at approximately 1,540
meters per second and
reflect back as
echoes to the transducer at	Identical

Table 2: Comparison of Technological Characteristics with the Predicate Device

117

118

ACUSON Sequoia ACUSON Sequoia Diagnostic Ultrasound Diagnostic Ultrasound Standard Svstem System Comparison Feature K# Pending K201462 (Subject Device) (Predicate Device) tissue density, for tissue density, for example, at the example, at the border of two organs in border of two organs in the body. These return the body. These return provide provide signals signals information about the information about the acoustic properties of the acoustic properties of the tissue. The time to receive tissue. The time to receive the echo in microseconds the echo in microseconds indicates a indicates a distance into the body. distance into the body. Structures furthest from Structures furthest from the transducer surface the transducer surface require more time to require more time to return a signal than return a signal than structures closer to the structures closer to the transducer surface. The transducer surface. The strength and position of strength and position of each signal indicates a each signal indicates a point of varying intensity point of varying intensity (brightness). (brightness). The The distances and intensities distances and intensities are processed -and are are are processed and displayed on a screen to displayed on a screen to form a two-dimensional form a two-dimensional (2D) (2D) image. image. Curved Array Transducer Curved Array Transducer Linear Array Transducer Linear Array Transducer Type of Phased Array Transducer Phased Array Transducer Previously Continuous Wave Continuous Wave Identical cleared Transducers Transducers Transducers Curved Array Mechanical Curved Array Mechanical 3D Transducer 3D Transducer Acoustic Yes Yes Identical Outputs Within Range? Previously cleared Yes Yes Identical Imaging Modes?

ACUSON DIAGNOSTIC ULTRASOUND SYSTEMS UPDATE Special 510(k)

Siemens Medical Solutions USA, Inc. Ultrasound Division

119

| Standard
Feature | ACUSON Sequoia
Diagnostic Ultrasound
System
K# Pending
(Subject Device) | ACUSON Sequoia
Diagnostic Ultrasound
System
K201462
(Predicate Device) | Comparison |
|---------------------|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|------------|
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Identical |

	ACUSON SC2000	ACUSON SC2000
	Diagnostic Ultrasound	Diagnostic Ultrasound
Standard Feature	System	System	Comparison
	K# Pending	K200585
	(Subject Device)	(Predicate Device)
	The SC2000 ultrasound	The SC2000 ultrasound
	imaging system is intended	imaging system is intended
	for the following	for the following
	applications:	applications:
	Cardiac,
Neo-natal and Fetal	Cardiac,
Neo-natal and Fetal
	Cardiac, Pediatric,	Cardiac, Pediatric,
	Transesophageal, Adult	Transesophageal, Adult
	Cephalic, Peripheral	Cephalic, Peripheral
	Vessel, Abdominal,	Vessel, Abdominal,
	Intraoperative Abdominal,	Intraoperative Abdominal,
	Musculo-skeletal	Musculo-skeletal
	Conventional, and	Conventional, and
	Musculo-skeletal	Musculo-skeletal
	Superficial applications.	Superficial applications.
	The system also provides	The system also provides
Indications for
Use	the ability to measure
anatomical structures and	the ability to measure
anatomical structures and	Identical
	calculation packages that
provide information to the	calculation packages that
provide information to the
	clinician that may be used	clinician that may be used
	adjunctively with other	adjunctively with other
	medical data obtained by a	medical data obtained by a
	physician for clinical	physician for clinical
	diagnosis purposes.	diagnosis purposes.
	The typical examinations	The typical examinations
	performed using the	performed using the
	SC2000 Ultrasound	SC2000 Ultrasound
	System are:	System are:
	Cardiac Imaging
Applications and Analysis	Cardiac Imaging
Applications and Analysis
	The system transmits
ultrasound energy into	The system transmits
ultrasound energy into
Standard Feature	ACUSON SC2000
Diagnostic Ultrasound
System
K# Pending
(Subject Device)	ACUSON SC2000
Diagnostic Ultrasound
System
K200585
(Predicate Device)	Comparison
	adult, pediatric, neonatal,
and fetal cardiac patients
creating 2D (B), 3D,
MMode (M), Color
Doppler (CD), Color
Power Doppler (CPD),
Pulsed Wave (PW)
Doppler, and Continuous
Wave Doppler (CWD) to
obtain images and blood
flow velocity of the heart,
cardiac valves, great
vessels, and surrounding
anatomical structures to
evaluate the presence or
absence of pathology. The
system may be used to
acquire patient
electrocardiogram for
synchronizing the diastolic
and systolic capture of
ultrasound images.
The system also supports
catheters which are
intended for intra-cardiac
and intraluminal
visualization of cardiac
and great vessel anatomy
and physiology as well as
visualization of other
devices in the heart of adult
and pediatric patients. The
catheter is intended for
imaging guidance only, not
treatment delivery, during
cardiac interventional
percutaneous procedures.
The system has Cardiac
Measurements and
Calculation Packages that
provide information that	adult, pediatric, neonatal,
and fetal cardiac patients
creating 2D (B), 3D,
MMode (M), Color
Doppler (CD), Color
Power Doppler (CPD),
Pulsed Wave (PW)
Doppler, and Continuous
Wave Doppler (CWD) to
obtain images and blood
flow velocity of the heart,
cardiac valves, great
vessels, and surrounding
anatomical structures to
evaluate the presence or
absence of pathology. The
system may be used to
acquire patient
electrocardiogram for
synchronizing the diastolic
and systolic capture of
ultrasound images.
The system also supports
catheters which are
intended for intra-cardiac
and intraluminal
visualization of cardiac
and great vessel anatomy
and physiology as well as
visualization of other
devices in the heart of adult
and pediatric patients. The
catheter is intended for
imaging guidance only, not
treatment delivery, during
cardiac interventional
percutaneous procedures.
The system has Cardiac
Measurements and
Calculation Packages that
provide information that
Standard Feature	ACUSON SC2000
Diagnostic Ultrasound
System
K# Pending
(Subject Device)	ACUSON SC2000
Diagnostic Ultrasound
System
K200585
(Predicate Device)	Comparison
	may be used adjunctively
with other medical data
obtained by a physician for
clinical diagnosis
purposes.
Vascular Imaging
Applications and Analysis
The system transmits
ultrasound energy into
various parts of the body of
adult patients creating 2D
(B), Color Doppler (CD),
Color Power Doppler
(CPD), Pulsed Wave
Doppler (PWD), and
Continuous Wave Doppler
(CWD) to obtain images
and blood flow velocity of
the carotid arteries or
juggler veins in the neck;
superficial and deep veins
and arteries in the arms and
legs and abdomen; and
surrounding anatomical
structures to evaluate the
presence or absence of
pathology. The system
may be used to acquire
patient electrocardiogram
for synchronizing the
diastolic and systolic
capture of ultrasound
images. The system has
Vascular Measurements
and Calculation Packages
that provide information
that may be used
adjunctively with other
medical data obtained by a
physician for clinical
diagnosis purposes.	may be used adjunctively
with other medical data
obtained by a physician for
clinical diagnosis
purposes.
Vascular Imaging
Applications and Analysis
The system transmits
ultrasound energy into
various parts of the body of
adult patients creating 2D
(B), Color Doppler (CD),
Color Power Doppler
(CPD), Pulsed Wave
Doppler (PWD), and
Continuous Wave Doppler
(CWD) to obtain images
and blood flow velocity of
the carotid arteries or
juggler veins in the neck;
superficial and deep veins
and arteries in the arms and
legs and abdomen; and
surrounding anatomical
structures to evaluate the
presence or absence of
pathology. The system
may be used to acquire
patient electrocardiogram
for synchronizing the
diastolic and systolic
capture of ultrasound
images. The system has
Vascular Measurements
and Calculation Packages
that provide information
that may be used
adjunctively with other
medical data obtained by a
physician for clinical
diagnosis purposes.
Standard Feature	ACUSON SC2000
Diagnostic Ultrasound
System
K# Pending
(Subject Device)	ACUSON SC2000
Diagnostic Ultrasound
System
K200585
(Predicate Device)	Comparison
	Superficial Imaging
Applications
The system transmits
ultrasound energy into
various parts of the body of
adult patients creating 2D
(B), Color Doppler (CD),
Color Power Doppler
(CPD), Pulsed Wave
Doppler (PWD), and
Continuous Wave Doppler
(CWD) to obtain images
and blood flow velocity of
conventional or superficial
musculoskeletal structures
and surrounding
anatomical structures to
evaluate the presence or
absence of pathology. The
system may be used to
acquire patient
electrocardiogram for
synchronizing the diastolic
and systolic capture of
ultrasound images.	Superficial Imaging
Applications
The system transmits
ultrasound energy into
various parts of the body of
adult patients creating 2D
(B), Color Doppler (CD),
Color Power Doppler
(CPD), Pulsed Wave
Doppler (PWD), and
Continuous Wave Doppler
(CWD) to obtain images
and blood flow velocity of
conventional or superficial
musculoskeletal structures
and surrounding
anatomical structures to
evaluate the presence or
absence of pathology. The
system may be used to
acquire patient
electrocardiogram for
synchronizing the diastolic
and systolic capture of
ultrasound images.
	Intraoperative Imaging
Applications
The system transmits
ultrasound energy into
various parts of the body of
adult patients creating 2D
(B), Color Doppler (CD),
Color Power Doppler
(CPD), and Pulsed Wave
Doppler (PWD) to obtain
images and blood flow
velocity that provide
guidance during
intraoperative procedures.
Transcranial Imaging
Applications	Intraoperative Imaging
Applications
The system transmits
ultrasound energy into
various parts of the body of
adult patients creating 2D
(B), Color Doppler (CD),
Color Power Doppler
(CPD), and Pulsed Wave
Doppler (PWD) to obtain
images and blood flow
velocity that provide
guidance during
intraoperative procedures.
Transcranial Imaging
Applications
Standard Feature	ACUSON SC2000
Diagnostic Ultrasound
System
K# Pending
(Subject Device)	ACUSON SC2000
Diagnostic Ultrasound
System
K200585
(Predicate Device)	Comparison
	The system transmits
ultrasound energy into the
cranium of adult patients
creating 2D (B), Color
Doppler (CD), Color
Power Doppler (CPD),
Pulsed Wave Doppler
(PWD), and Continuous
Wave Doppler (CWD) to
obtain images and blood
flow velocity of the brain
and surrounding
anatomical structures to
evaluate the presence or
absence of pathology. The
system provides
Measurement Packages
that provide information
that may be used
adjunctively with other
medical data obtained by a
physician for clinical
diagnosis purposes.	The system transmits
ultrasound energy into the
cranium of adult patients
creating 2D (B), Color
Doppler (CD), Color
Power Doppler (CPD),
Pulsed Wave Doppler
(PWD), and Continuous
Wave Doppler (CWD) to
obtain images and blood
flow velocity of the brain
and surrounding
anatomical structures to
evaluate the presence or
absence of pathology. The
system provides
Measurement Packages
that provide information
that may be used
adjunctively with other
medical data obtained by a
physician for clinical
diagnosis purposes.
Reusable?	Yes	Yes	Identical
Duration of Use	Limited (≤ 24 hours)	Limited (≤ 24 hours)	Identical
Scientific
Technology	Ultrasound Imaging	Ultrasound Imaging	Identical
	Diagnostic ultrasound uses
high-frequency (above the
audible range) sound
waves to
produce an image of
anatomical structures
within the body. Electrical
pulses vibrate
ceramics within a
transducer to transmit the
sound waves into the body.
Sound waves
travel through body tissue
at approximately 1 540	Diagnostic ultrasound uses
high-frequency (above the
audible range) sound
waves to
produce an image of
anatomical structures
within the body. Electrical
pulses vibrate
ceramics within a
transducer to transmit the
sound waves into the body.
Sound waves
travel through body tissue
at approximately 1 540
Operating
principles			Identical
Standard Feature	ACUSON SC2000
Diagnostic Ultrasound
System
K# Pending
(Subject Device)	ACUSON SC2000
Diagnostic Ultrasound
System
K200585
(Predicate Device)	Comparison
	meters per second and
reflect back as
echoes to the transducer at
each point of change in
tissue density, for example,
at the
border of two organs in the
body. These return signals
provide information about
the
acoustic properties of the
tissue. The time to receive
the echo in microseconds
indicates a
distance into the body.
Structures furthest from
the transducer surface
require more time to return
a signal than structures
closer to the transducer
surface. The strength and
position of each signal
indicates a point of varying
intensity (brightness). The
distances and intensities
are processed and
displayed on a screen to
form a two-dimensional
(2D)
image.	meters per second and
reflect back as
echoes to the transducer at
each point of change in
tissue density, for example,
at the
border of two organs in the
body. These return signals
provide information about
the
acoustic properties of the
tissue. The time to receive
the echo in microseconds
indicates a
distance into the body.
Structures furthest from
the transducer surface
require more time to return
a signal than structures
closer to the transducer
surface. The strength and
position of each signal
indicates a point of varying
intensity (brightness). The
distances and intensities
are processed and
displayed on a screen to
form a two-dimensional
(2D)
image.
Type of
Previously
cleared
Transducers	Curved Array Transducer
Linear Array Transducer
Phased Array Transducer
Continuous Wave
Transducers
Transesophageal
Transducer
Ultrasound Catheter	Curved Array Transducer
Linear Array Transducer
Phased Array Transducer
Continuous Wave
Transducers
Transesophageal
Transducer
Ultrasound Catheter	Identical
Acoustic Outputs	Yes	Yes	Identical
Standard Feature	ACUSON SC2000
Diagnostic Ultrasound
System
K# Pending
(Subject Device)	ACUSON SC2000
Diagnostic Ultrasound
System
K200585
(Predicate Device)	Comparison
Previously
cleared
Imaging Modes?	Yes	Yes	Identical
Biocompatibility	ISO 10993-1	ISO 10993-1	Identical

ACUSON SC2000

120

121

Siemens Medical Solutions USA, Inc.
Ultrasound Division

122

123

124

125

| Standard Feature | ACUSON Freestyle
Diagnostic Ultrasound
System
K# Pending
(Subject Device) | ACUSON Freestyle
Diagnostic Ultrasound
System
K200644
(Predicate Device) | Comparison |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for
Use | The ACUSON Freestyle
Ultrasound System is
intended for diagnostic
imaging or fluid flow
analysis of the human
body performed by an
appropriately trained
healthcare professional in
a healthcare setting for the
following conditions:
Abdominal, Pediatric,
Small Organ, Peripheral
Vessel, Musculoskeletal
(Conventional),
Musculoskeletal
(Superficial). | The ACUSON Freestyle
Ultrasound System is
intended for diagnostic
imaging or fluid flow
analysis of the human
body performed by an
appropriately trained
healthcare professional in
a healthcare setting for the
following conditions:
Abdominal, Pediatric,
Small Organ, Peripheral
Vessel, Musculoskeletal
(Conventional),
Musculoskeletal
(Superficial). | Identical |
| Reusable? | Yes | Yes | Identical |
| Duration of Use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical |
| Scientific
Technology | Ultrasound Imaging | Ultrasound Imaging | Identical |
| Operating
principles | Diagnostic ultrasound uses
high-frequency (above the
audible range) sound
waves to
produce an image of
anatomical structures | Diagnostic ultrasound uses
high-frequency (above the
audible range) sound
waves to
produce an image of
anatomical structures | Identical |
| Standard Feature | ACUSON Freestyle
Diagnostic Ultrasound
System
K# Pending
(Subject Device) | ACUSON Freestyle
Diagnostic Ultrasound
System
K200644
(Predicate Device) | Comparison |
| | within the body. Electrical
pulses vibrate
ceramics within a
transducer to transmit the
sound waves into the body.
Sound waves
travel through body tissue
at approximately 1,540
meters per second and
reflect back as
echoes to the transducer at
each point of change in
tissue density, for
example, at the
border of two organs in the
body. These return signals
provide information about
the
acoustic properties of the
tissue. The time to receive
the echo in microseconds
indicates a
distance into the body.
Structures furthest from
the transducer surface
require more time to return
a signal than structures
closer to the transducer
surface. The strength and
position of each signal
indicates a point of varying
intensity (brightness). The
distances and intensities
are processed and
displayed on a screen to
form a two-dimensional
(2D)
image. | within the body. Electrical
pulses vibrate
ceramics within a
transducer to transmit the
sound waves into the body.
Sound waves
travel through body tissue
at approximately 1,540
meters per second and
reflect back as
echoes to the transducer at
each point of change in
tissue density, for
example, at the
border of two organs in the
body. These return signals
provide information about
the
acoustic properties of the
tissue. The time to receive
the echo in microseconds
indicates a
distance into the body.
Structures furthest from
the transducer surface
require more time to return
a signal than structures
closer to the transducer
surface. The strength and
position of each signal
indicates a point of varying
intensity (brightness). The
distances and intensities
are processed and
displayed on a screen to
form a two-dimensional
(2D)
image. | |
| Type of
Previously
cleared | Curved Array Transducer
Linear Array Transducer | Curved Array Transducer
Linear Array Transducer | Identical |
| Standard Feature | ACUSON Freestyle
Diagnostic Ultrasound
System
K# Pending
(Subject Device) | ACUSON Freestyle
Diagnostic Ultrasound
System
K200644
(Predicate Device) | Comparison |
| Transducers | | | |
| Acoustic Outputs
Within Range? | Yes | Yes | Identical |
| Previously
cleared | Yes | Yes | Identical |
| Imaging Modes? | | | |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Identical |

ACUSON Freestyle

Siemens Medical Solutions USA, Inc. Ultrasound Division

126

127

| Standard
Feature | ACUSON S family
(S1000/S2000/S3000)
Diagnostic Ultrasound
System
K# Pending
(Subject Device) | ACUSON S family
(S1000/S2000/S3000)
Diagnostic Ultrasound
System
K172162
(Predicate Device) | Comparison |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for
Use | The ultrasound imaging
systems are intended for the
following applications:
Fetal, Abdominal,
Intraoperative, Pediatric,
Small Parts, Transcranial,
OB/GYN (including
monitoring of the ovarian
follicle development),
Cardiac, Pelvic,
Neonatal/Adult Cephalic,
Vascular, Musculoskeletal,
Superficial
Musculoskeletal, and
Peripheral Vascular
applications.

The system also provides
the ability to measure
anatomical structures | The ultrasound imaging
systems are intended for the
following applications:
Fetal, Abdominal,
Intraoperative, Pediatric,
Small Parts, Transcranial,
OB/GYN (including
monitoring of the ovarian
follicle development),
Cardiac, Pelvic,
Neonatal/Adult Cephalic,
Vascular, Musculoskeletal,
Superficial
Musculoskeletal, and
Peripheral Vascular
applications.

The system also provides
the ability to measure
anatomical structures | Identical |
| Standard Feature | ACUSON S family (S1000/S2000/S3000) Diagnostic Ultrasound System K# Pending (Subject Device) | ACUSON S family (S1000/S2000/S3000) Diagnostic Ultrasound System K172162 (Predicate Device) | Comparison |
| | {fetal, abdominal, intraoperative, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. | {fetal, abdominal, intraoperative, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. | |
| | The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the “ASE Consensus Statement; Use of Carotid Ultrasound to Identify | The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the “ASE Consensus Statement; Use of Carotid Ultrasound to Identify | |
| Standard
Feature | ACUSON S family
(S1000/S2000/S3000)
Diagnostic Ultrasound
System
K# Pending
(Subject Device) | ACUSON S family
(S1000/S2000/S3000)
Diagnostic Ultrasound
System
K172162
(Predicate Device) | Comparison |
| | Subclinical Vascular
Disease and Evaluate
Cardiovascular Disease
Risk: A Consensus
Statement from the
American Association of
Echocardiography; Carotid
Intima-Media Thickness
Task Force, Endorsed by
the Society for Vascular
Imaging". | Subclinical Vascular
Disease and Evaluate
Cardiovascular Disease
Risk: A Consensus
Statement from the
American Association of
Echocardiography; Carotid
Intima-Media Thickness
Task Force, Endorsed by
the Society for Vascular
Imaging". | |
| | The ACUSON AcuNav
Ultrasound Catheter is
intended for intra-cardiac
and intra-luminal
visualization of cardiac and
great vessel anatomy and
physiology, as well as
visualization of other
devices in the heart of adult
and pediatric patients. | The ACUSON AcuNav
Ultrasound Catheter is
intended for intra-cardiac
and intra-luminal
visualization of cardiac and
great vessel anatomy and
physiology, as well as
visualization of other
devices in the heart of adult
and pediatric patients. | |
| Reusable? | Yes | Yes | Identical |
| Duration of Use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical |
| Scientific
Technology | Ultrasound Imaging | Ultrasound Imaging | Identical |
| Operating
principles | Diagnostic ultrasound uses
high-frequency (above the
audible range) sound waves
to
produce an image of
anatomical structures
within the body. Electrical
pulses vibrate
ceramics within a
transducer to transmit the
sound waves into the body.
Sound waves
travel through body tissue
at approximately 1,540 | Diagnostic ultrasound uses
high-frequency (above the
audible range) sound waves
to
produce an image of
anatomical structures
within the body. Electrical
pulses vibrate
ceramics within a
transducer to transmit the
sound waves into the body.
Sound waves
travel through body tissue
at approximately 1,540 | Identical |
| Standard
Feature | ACUSON S family
(S1000/S2000/S3000)
Diagnostic Ultrasound
System
K# Pending
(Subject Device) | ACUSON S family
(S1000/S2000/S3000)
Diagnostic Ultrasound
System
K172162
(Predicate Device) | Comparison |
| | meters per second and
reflect back as
echoes to the transducer at
each point of change in
tissue density, for example,
at the
border of two organs in the
body. These return signals
provide information about
the
acoustic properties of the
tissue. The time to receive
the echo in microseconds
indicates a
distance into the body.
Structures furthest from the
transducer surface require
more time to return a signal
than structures closer to the
transducer surface. The
strength and position of
each signal indicates a
point of varying intensity
(brightness). The distances
and intensities are
processed and displayed on
a screen to form a two-
dimensional (2D)
image. | meters per second and
reflect back as
echoes to the transducer at
each point of change in
tissue density, for example,
at the
border of two organs in the
body. These return signals
provide information about
the
acoustic properties of the
tissue. The time to receive
the echo in microseconds
indicates a
distance into the body.
Structures furthest from the
transducer surface require
more time to return a signal
than structures closer to the
transducer surface. The
strength and position of
each signal indicates a
point of varying intensity
(brightness). The distances
and intensities are
processed and displayed on
a screen to form a two-
dimensional (2D)
image. | |
| Type of
Previously
cleared
Transducers | Curved Array Transducer
Linear Array Transducer
Phased Array Transducer
Continuous Wave
Transducers
Curved Array Mechanical
3D Transducer
Transesophageal
Transducer
Ultrasound Catheter | Curved Array Transducer
Linear Array Transducer
Phased Array Transducer
Continuous Wave
Transducers
Curved Array Mechanical
3D Transducer
Transesophageal
Transducer
Ultrasound Catheter | Identical |
| Standard
Feature | ACUSON S family
(S1000/S2000/S3000)
Diagnostic Ultrasound
System
K# Pending
(Subject Device) | ACUSON S family
(S1000/S2000/S3000)
Diagnostic Ultrasound
System
K172162
(Predicate Device) | Comparison |
| Within Range? | | | |
| Previously
cleared
Imaging Modes? | Yes | Yes | Identical |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Identical |

ACUSON S-Family

128

129

130

131

| Standard Feature | ACUSON P200
Diagnostic Ultrasound
System
K# Pending
(Subject Device) | ACUSON P200
Diagnostic Ultrasound
System
K191922
(Predicate Device) | Comparison |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for
Use | The ACUSON P200
ultrasound imaging system
is intended for the
following applications:
Fetal, Abdominal,
Pediatric, Small Parts,
OB/GYN (useful for
visualization of the
ovaries, follicles, uterus,
and other pelvic
structures), Adult,
Pediatric and Neonatal
Cardiac, Pelvic, Neonatal
Cephalic, Vascular,
Musculoskeletal,
Superficial
Musculoskeletal, and | The ACUSON P200
ultrasound imaging system
is intended for the
following applications:
Fetal, Abdominal,
Pediatric, Small Parts,
OB/GYN (useful for
visualization of the
ovaries, follicles, uterus,
and other pelvic
structures), Adult,
Pediatric and Neonatal
Cardiac, Pelvic, Neonatal
Cephalic, Vascular,
Musculoskeletal,
Superficial
Musculoskeletal, and | Identical |
| Standard Feature | ACUSON P200
Diagnostic Ultrasound
System
K# Pending
(Subject Device) | ACUSON P200
Diagnostic Ultrasound
System
K191922
(Predicate Device) | Comparison |
| | Peripheral Vascular
applications.

The system also provides
the ability to measure
anatomical structures;
fetal, abdominal, pediatric,
small organ, neonatal
cephalic, cardiac (adult,
pediatric and neonatal),
trans-esophageal,
transrectal, transvaginal,
peripheral vessel,
musculoskeletal
(conventional),
musculoskeletal
(superficial) and
calculation packages that
provide information to the
clinician that may be used
adjunctively with other
medical data obtained by a
physician for clinical
diagnosis purposes. | Peripheral Vascular
applications.

The system also provides
the ability to measure
anatomical structures;
fetal, abdominal, pediatric,
small organ, neonatal
cephalic, cardiac (adult,
pediatric and neonatal),
trans-esophageal,
transrectal, transvaginal,
peripheral vessel,
musculoskeletal
(conventional),
musculoskeletal
(superficial) and
calculation packages that
provide information to the
clinician that may be used
adjunctively with other
medical data obtained by a
physician for clinical
diagnosis purposes. | |
| Reusable? | Yes | Yes | Identical |
| Duration of Use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical |
| Scientific
Technology | Ultrasound Imaging | Ultrasound Imaging | Identical |
| Operating
principles | Diagnostic ultrasound uses
high-frequency (above the
audible range) sound
waves to
produce an image of
anatomical structures
within the body. Electrical
pulses vibrate
ceramics within a
transducer to transmit the
sound waves into the body.
Sound waves | Diagnostic ultrasound uses
high-frequency (above the
audible range) sound
waves to
produce an image of
anatomical structures
within the body. Electrical
pulses vibrate
ceramics within a
transducer to transmit the
sound waves into the body.
Sound waves | Identical |
| Standard Feature | ACUSON P200
Diagnostic Ultrasound
System
K# Pending
(Subject Device) | ACUSON P200
Diagnostic Ultrasound
System
K191922
(Predicate Device) | Comparison |
| | travel through body tissue
at approximately 1,540
meters per second and
reflect back as
echoes to the transducer at
each point of change in
tissue density, for
example, at the
border of two organs in the
body. These return signals
provide information about
the
acoustic properties of the
tissue. The time to receive
the echo in microseconds
indicates a
distance into the body.
Structures furthest from
the transducer surface
require more time to return
a signal than structures
closer to the transducer
surface. The strength and
position of each signal
indicates a point of varying
intensity (brightness). The
distances and intensities
are processed and
displayed on a screen to
form a two-dimensional
(2D)
image. | travel through body tissue
at approximately 1,540
meters per second and
reflect back as
echoes to the transducer at
each point of change in
tissue density, for
example, at the
border of two organs in the
body. These return signals
provide information about
the
acoustic properties of the
tissue. The time to receive
the echo in microseconds
indicates a
distance into the body.
Structures furthest from
the transducer surface
require more time to return
a signal than structures
closer to the transducer
surface. The strength and
position of each signal
indicates a point of varying
intensity (brightness). The
distances and intensities
are processed and
displayed on a screen to
form a two-dimensional
(2D)
image. | |
| Type of
Previously
cleared
Transducers | Curved Array Transducer
Linear Array Transducer
Phased Array Transducer
Continuous Wave
Transducers
Transesophageal
Transducer | Curved Array Transducer
Linear Array Transducer
Phased Array Transducer
Continuous Wave
Transducers
Transesophageal
Transducer | Identical |
| Acoustic Outputs
Within Range? | Yes | Yes | Identical |
| Standard Feature | ACUSON P200
Diagnostic Ultrasound
System
K# Pending
(Subject Device) | ACUSON P200
Diagnostic Ultrasound
System
K191922
(Predicate Device) | Comparison |
| Previously
cleared
Imaging Modes? | Yes | Yes | Identical |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Identical |

ACUSON P200

132

133

134

ACUSON P500

| Standard
Feature | ACUSON P500
Ultrasound System
K# Pending
(Subject Device) | ACUSON P500
Ultrasound System
K163396
(Predicate Device) | Comparison |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for
Use | The ACUSON P500
ultrasound imaging system
is intended for the
following applications:
Fetal, Abdominal
(including liver), Pediatric,
Small Parts, Transcranial,
OB/GYN(useful for
visualization of ovaries,
follicles, uterus and other
pelvic structures), Pelvic,
Neonatal, Cardiac,
IntraCardiac,
Vascular(including
Peripheral Vessel),
Musculoskeletal,
Superficial
Musculoskeletal, and
Urology applications.

The system also provides
the ability to measure
anatomical structures fetal,
abdominal, small organ,
transrectal, transvaginal,
cardiovascular, peripheral
vessel, musculoskeletal
(conventional) and | The ACUSON P500
ultrasound imaging system
is intended for the
following applications:
Fetal, Abdominal
(including liver), Pediatric,
Small Parts, Transcranial,
OB/GYN(useful for
visualization of ovaries,
follicles, uterus and other
pelvic structures), Pelvic,
Neonatal, Cardiac,
IntraCardiac,
Vascular(including
Peripheral Vessel),
Musculoskeletal,
Superficial
Musculoskeletal, and
Urology applications.

The system also provides
the ability to measure
anatomical structures fetal,
abdominal, small organ,
transrectal, transvaginal,
cardiovascular, peripheral
vessel, musculoskeletal
(conventional) and | Identical |
| Standard Feature | ACUSON P500
Ultrasound System
K# Pending
(Subject Device) | ACUSON P500
Ultrasound System
K163396
(Predicate Device) | Comparison |
| | musculoskeletal
(superficial) and
calculation packages that
provide information to the
clinician that may be used
adjunctively with other
medical data obtained by a
physician for clinical
diagnosis purposes. | musculoskeletal
(superficial) and
calculation packages that
provide information to the
clinician that may be used
adjunctively with other
medical data obtained by a
physician for clinical
diagnosis purposes. | |
| | The Arterial Health
Package (AHP) software
provides the physician with
the capability to measure
Intima Media Thickness
and the option to reference
normative tables that have
been validated and
published in peer-reviewed
studies. The information is
intended to provide the
physician with an easily
understood tool for
communicating with
patients regarding state of
their cardiovascular
system. | The Arterial Health
Package (AHP) software
provides the physician with
the capability to measure
Intima Media Thickness
and the option to reference
normative tables that have
been validated and
published in peer-reviewed
studies. The information is
intended to provide the
physician with an easily
understood tool for
communicating with
patients regarding state of
their cardiovascular
system. | |
| | This feature should be
utilized according to the
"ASE Consensus
Statement; Use of Carotid
Ultrasound to Identify
Subclinical Vascular
Disease and Evaluate
Cardiovascular Disease
Risk: A Consensus
Statement from the
American Society of
Echocardiography Carotid
Intima-Media Thickness | This feature should be
utilized according to the
"ASE Consensus
Statement; Use of Carotid
Ultrasound to Identify
Subclinical Vascular
Disease and Evaluate
Cardiovascular Disease
Risk: A Consensus
Statement from the
American Society of
Echocardiography Carotid
Intima-Media Thickness | |
| Standard Feature | ACUSON P500
Ultrasound System
K# Pending
(Subject Device) | ACUSON P500
Ultrasound System
K163396
(Predicate Device) | Comparison |
| | the Society for Vascular
Imaging." | the Society for Vascular
Imaging." | |
| | The ACUSON Acunav
Ultrasound Catheter is
intended for intra-cardiac
and intra-luminal
visualization of cardiac and
great vessel anatomy and
physiology, as well as
visualization of other
devices in the heart of adult
and pediatric patients. | The ACUSON Acunav
Ultrasound Catheter is
intended for intra-cardiac
and intra-luminal
visualization of cardiac and
great vessel anatomy and
physiology, as well as
visualization of other
devices in the heart of adult
and pediatric patients. | |
| Reusable? | Yes | Yes | Identical |
| Duration of Use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical |
| Scientific
Technology | Ultrasound Imaging | Ultrasound Imaging | Identical |
| | | | |
| | Diagnostic ultrasound uses
high-frequency (above the
audible range) sound
waves to
produce an image of
anatomical structures
within the body. Electrical
pulses vibrate
ceramics within a
transducer to transmit the
sound waves into the body. | Diagnostic ultrasound uses
high-frequency (above the
audible range) sound
waves to
produce an image of
anatomical structures
within the body. Electrical
pulses vibrate
ceramics within a
transducer to transmit the
sound waves into the body. | |
| Operating
principles | Sound waves
travel through body tissue
at approximately 1,540
meters per second and
reflect back as
echoes to the transducer at
each point of change in
tissue density, for example,
at the
border of two organs in the
body. These return signals
provide information about
the | Sound waves
travel through body tissue
at approximately 1,540
meters per second and
reflect back as
echoes to the transducer at
each point of change in
tissue density, for example,
at the
border of two organs in the
body. These return signals
provide information about
the | Identical |
| Standard
Feature | ACUSON P500
Ultrasound System
K# Pending
(Subject Device) | ACUSON P500
Ultrasound System
K163396
(Predicate Device) | Comparison |
| | acoustic properties of the
tissue. The time to receive
the echo in microseconds
indicates a
distance into the body.
Structures furthest from the
transducer surface require
more time to return a signal
than structures closer to the
transducer surface. The
strength and position of
each signal indicates a
point of varying intensity
(brightness). The distances
and
intensities are
processed and displayed on
a screen to form a two-
dimensional (2D)
image. | acoustic properties of the
tissue. The time to receive
the echo in microseconds
indicates a
distance into the body.
Structures furthest from the
transducer surface require
more time to return a signal
than structures closer to the
transducer surface. The
strength and position of
each signal indicates a
point of varying intensity
(brightness). The distances
and
intensities are
processed and displayed on
a screen to form a two-
dimensional (2D)
image. | |
| Type of
Previously
cleared
Transducers | Curved Array Transducer
Linear Array Transducer
Phased Array Transducer
Continuous Wave
Transducers
Ultrasound Catheter | Curved Array Transducer
Linear Array Transducer
Phased Array Transducer
Continuous Wave
Transducers
Ultrasound Catheter | Identical |
| Acoustic Outputs
Within Range? | Yes | Yes | Identical |
| Previously
cleared
Imaging Modes? | Yes | Yes | Identical |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Identical |

135

136

137

ACUSON NX3/NX3 Elite

| Standard
Feature | ACUSON NX3/NX3
Elite Diagnostic
Ultrasound System
K# Pending
(Subject Device) | ACUSON NX3/NX3
Elite Diagnostic
Ultrasound System
K192835
(Predicate Device) | Comparison |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for
Use | ACUSON NX3 | ACUSON NX3 | Identical |
| Standard
Feature | ACUSON NX3/NX3
Elite Diagnostic
Ultrasound System
K# Pending
(Subject Device) | ACUSON NX3/NX3
Elite Diagnostic
Ultrasound System
K192835
(Predicate Device) | Comparison |
| | The ACUSON NX3
ultrasound imaging system
is intended for the
following applications:
| The ACUSON NX3
ultrasound imaging system
is intended for the
following applications:
Fetal Abdominal
(including liver), Pediatric,
Small Parts (Small Organ),
Neonatal Cephalic, Adult
Cephalic, Transcranial,
OB/GYN, Pelvic,
Neonatal, Cardiac,
Vascular (including
Peripheral Vessel),
Musculoskeletal,
Superficial
Musculoskeletal and
Urology applications. | |
| | The systems also provide
for the measurement of
anatomical structures and
for analysis packages that
provide information that is
used for clinical diagnosis
purposes. | The systems also provide
for the measurement of
anatomical structures and
for analysis packages that
provide information that is
used for clinical diagnosis
purposes. | |
| | ACUSON NX3 Elite
The ACUSON NX3 Elite
ultrasound imaging system
is intended for the
following applications:
Fetal, Abdominal
(including liver, intra-
operative), Pediatric, Small
Parts (Small Organ
including intra-operative),
Neonatal Cephalic, Adult
Cephalic, Transcranial,
OB/GYN, Pelvic,
Neonatal, Cardiac,
Vascular (including | ACUSON NX3 Elite
The ACUSON NX3 Elite
ultrasound imaging system
is intended for the
following applications:
Fetal, Abdominal
(including liver, intra-
operative), Pediatric, Small
Parts (Small Organ
including intra-operative),
Neonatal Cephalic, Adult
Cephalic, Transcranial,
OB/GYN, Pelvic,
Neonatal, Cardiac,
Vascular (including | |
| Standard
Feature | ACUSON NX3/NX3
Elite Diagnostic
Ultrasound System
K# Pending
(Subject Device) | ACUSON NX3/NX3
Elite Diagnostic
Ultrasound System
K192835
(Predicate Device) | Comparison |
| | Peripheral Vessel, intra-
operative),
Musculoskeletal,
Superficial
Musculoskeletal and
Urology applications. | Peripheral Vessel, intra-
operative),
Musculoskeletal,
Superficial
Musculoskeletal and
Urology applications. | |
| | The systems also provide
for the measurement of
anatomical structures and
for analysis packages that
provide information that is
used for clinical diagnosis
purposes. | The systems also provide
for the measurement of
anatomical structures and
for analysis packages that
provide information that is
used for clinical diagnosis
purposes. | |
| | The Arterial Health
Package (AHP) software
provides the physician with
the capability to measure
Intima Media Thickness
and the option to reference
normative tables that have
been validated and
published in peer-reviewed
studies. The information is
intended to provide the
physician with an easily
understood tool for
communicating with
patients regarding state of
their cardiovascular
system. | The Arterial Health
Package (AHP) software
provides the physician with
the capability to measure
Intima Media Thickness
and the option to reference
normative tables that have
been validated and
published in peer-reviewed
studies. The information is
intended to provide the
physician with an easily
understood tool for
communicating with
patients regarding state of
their cardiovascular
system. | |
| | Note: This feature should
be utilized according to the
"ASE Consensus
Statement; Use of Carotid
Ultrasound to Identify
Subclinical Vascular
Disease and Evaluate
Cardiovascular Disease | Note: This feature should
be utilized according to the
"ASE Consensus
Statement; Use of Carotid
Ultrasound to Identify
Subclinical Vascular
Disease and Evaluate
Cardiovascular Disease | |
| Standard
Feature | ACUSON NX3/NX3
Elite Diagnostic
Ultrasound System
K# Pending
(Subject Device) | ACUSON NX3/NX3
Elite Diagnostic
Ultrasound System
K192835
(Predicate Device) | Comparison |
| | Risk: A Consensus
Statement from the
American Society of
Echocardiography; Carotid
Intima-Media Thickness
Task Force, Endorsed by
the Society for Vascular
Medicine.". | Risk: A Consensus
Statement from the
American Society of
Echocardiography; Carotid
Intima-Media Thickness
Task Force, Endorsed by
the Society for Vascular
Medicine.". | |
| Reusable? | Yes | Yes | Identical |
| Duration of Use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical |
| Scientific
Technology | Ultrasound Imaging | Ultrasound Imaging | Identical |
| Operating
principles | Diagnostic ultrasound uses
high-frequency (above the
audible range) sound
waves to
produce an image of
anatomical structures
within the body. Electrical
pulses vibrate
ceramics within a
transducer to transmit the
sound waves into the body.
Sound waves
travel through body tissue
at approximately 1,540
meters per second and
reflect back as
echoes to the transducer at
each point of change in
tissue density, for example,
at the
border of two organs in the
body. These return signals
provide information about
the
acoustic properties of the
tissue. The time to receive
the echo in microseconds
indicates a | Diagnostic ultrasound uses
high-frequency (above the
audible range) sound
waves to
produce an image of
anatomical structures
within the body. Electrical
pulses vibrate
ceramics within a
transducer to transmit the
sound waves into the body.
Sound waves
travel through body tissue
at approximately 1,540
meters per second and
reflect back as
echoes to the transducer at
each point of change in
tissue density, for example,
at the
border of two organs in the
body. These return signals
provide information about
the
acoustic properties of the
tissue. The time to receive
the echo in microseconds
indicates a | Identical |
| Standard Feature | ACUSON NX3/NX3
Elite Diagnostic
Ultrasound System
K# Pending
(Subject Device) | ACUSON NX3/NX3
Elite Diagnostic
Ultrasound System
K192835
(Predicate Device) | Comparison |
| | distance into the body. Structures furthest from the transducer surface require more time to return a signal than structures closer to the transducer surface. The strength and position of each signal indicates a point of varying intensity (brightness). The distances and intensities are processed and displayed on a screen to form a two-dimensional (2D) image. | distance into the body. Structures furthest from the transducer surface require more time to return a signal than structures closer to the transducer surface. The strength and position of each signal indicates a point of varying intensity (brightness). The distances and intensities are processed and displayed on a screen to form a two-dimensional (2D) image. | |
| Type of
Previously
cleared
Transducers | NX3
Curved Array Transducer
Linear Array Transducer
Phased Array Transducer
Curved Array Mechanical
3D Transducer

NX3 Elite
Curved Array Transducer
Linear Array Transducer
Phased Array Transducer
Continuous Wave
Transducers
Curved Array Mechanical
3D Transducer
Transesophageal
Transducer | NX3
Curved Array Transducer
Linear Array Transducer
Phased Array Transducer
Curved Array Mechanical
3D Transducer

NX3 Elite
Curved Array Transducer
Linear Array Transducer
Phased Array Transducer
Continuous Wave
Transducers
Curved Array Mechanical
3D Transducer
Transesophageal
Transducer | Identical |
| Acoustic Outputs
Within Range? | Yes | Yes | Identical |
| Previously
cleared
Imaging Modes? | Yes | Yes | Identical |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Identical |

Siemens Medical Solutions USA, Inc. Ultrasound Division

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Substantial Equivalence Conclusion:

From the information provided in Table 2 above: it is understood that the subject device does not introduce any new fundamental technology or modify the indications of use; therefore, the listed ACUSON Diagnostic Ultrasound systems as listed in Table 2 are considered substantially equivalent to their individual predicate devices including the expanded labeling.

Part 7. A brief discussion of nonclinical testing submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence.

The Customer Requirement Specifications (CRS) for each listed ACUSON Diagnostic Ultrasound device was verified and validated according to the design control requirements of 21 CFR 820.30 during the original project development of the predicate version of each device and remain unchanged from their currently cleared configuration. Each predicate version of the listed device has been subjected to extensive safety and requirements verification testing before release to ensure the device meets all its specifications including conformance to the following standards:

• IEC 62304:2006/A1:2016 Medical Device Software Software Life Cycle Processes ●
• IEC 62366-1:2015, Application of usability engineering to medical devices. .
• . NEMA PS 3.1 - 3.20 (2016), Digital Imaging and Communications in Medicine (DICOM set).

The testing results for each listed ACUSON Diagnostic Ultrasound System to support the claim of conformity are available upon request. There are no software or hardware modifications to any device under this review and the expanded labeling has no impact on the individual ACUSON ultrasound device, therefore, testing results are not included in this Special 510(k) submission.

For the expanded Labeling for each ACUSON Diagnostic Ultrasound Device as listed above, the use of currently cleared customizable PreSets will be supported by availability of the Educational materials and current literature currently posted on the Siemens Healthineers website and included in this submission under Labeling.

Software Verification and Validation

In accordance with the FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, documentation is included within this submission for software of a Moderate Level of Concern. Non-clinical Testing has been conducted during product development for each of the predicate ACUSON Diagnostic Ultrasound device described in this submission.

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The expanded Labeling for customer use of educational and training materials specifically for Lung Ultrasound imaging does not impact the software for any listed device.

Cybersecurity considerations related to the ACUSON Diagnostic Ultrasound systems device software has been address within each product. Siemens conforms to cybersecurity requirements by implementing a means to prevent unauthorized access, modification, misuse, denial of use or unauthorized use of information stored, accessed or transferred from a medical device to an external recipient.

A risk analysis, in compliance with ISO 14971:2007, for each of the ACUSON Diagnostic Ultrasound systems device during their development of the predicate devices was conducted and mitigation controls were implemented for identified hazards. Verification and validation testing confirm that all software specifications have been implemented on the respective predicate devices and met the defined acceptance criteria. The predicate devices remain unchanged from their currently cleared software version, configuration and accessories.

Note: Risk analysis was performed by the Risk management team by review of clinical literature.

Part 8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.

The ACUSON Diagnostic Ultrasound systems device are all FDA Class II devices and uses the same technology and operating principles as their respective predicate devices, therefore clinical studies were not required to support substantial equivalence, The expanded Labeling for Lung Ultrasound imaging (LUS) is supported by clinical literature.

Part 9. Safety and Effectiveness Information

The currently cleared Device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of each device listed. Risk management was implemented throughout the development process for each ACUSON Diagnostic Ultrasound system to control potential hazards. Siemens believes that the expanded Labeling is safe and effective for the use of instructions for Lunq ultrasound imaging (LUS) and does not introduce new safety and effectiveness concerns.

Part 10. Conclusion as to Substantial Equivalence Summary

Based on the information provided here in the summary and from the device comparison in Table 2; ACUSON Diagnostic Ultrasound systems have the same indications for use as the primary predicate devices. The device Labeling has been expanded to include information regarding the use of Ultrasound Imaging of the Lung imaging by the use of adequate descriptions necessary for training on scanning

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144

techniques for Lung imaging, description for Users to create Lung Preset settings by using the Preset Customization tools currently available on all cleared ACUSON devices indicated in this submission and referencing clinical information distributed to the clinicians various peer reviewed Journal articles.

There are no new features or software changes from the primary predicate devices and no new issues of safety or effectiveness are raised.

Siemens Medical Solutions USA, Inc, Ultrasound Business Unit considers the all of the ACUSON Diagnostic Ultrasound systems with expanded Labeling to be substantially equivalent with respect to safety and effectiveness to the previously cleared predicate devices for the U.S. market.