(34 days)
Not Found
No
The document describes a standard ultrasound system with various imaging modes and measurement packages. There is no mention of AI, ML, deep learning, or any related technologies in the intended use, device description, or performance studies sections. The device relies on established ultrasound technology and principles.
No
The device is described as a "diagnostic ultrasound system," and its intended use is for "clinical diagnosis purposes" and "visualization" of anatomy, not for treatment.
Yes
The "Device Description" explicitly states that "Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display." and refers to it as a "diagnostic ultrasound system". Additionally, the "Intended Use / Indications for Use" section mentions "calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes." and "The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness... The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system." All these indicate its use for diagnostic purposes.
No
The device description explicitly states it is a "multi-purpose mobile, software controlled diagnostic ultrasound system," indicating it includes hardware components (the ultrasound system itself) in addition to software.
Based on the provided information, the S3000™ ultrasound imaging system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that the S3000 is an ultrasound imaging system used to visualize anatomical structures and physiology within the body. It acquires ultrasound echo data directly from the patient.
- The intended use focuses on imaging and measurement of structures within the body. While it provides information that can be used adjunctively for clinical diagnosis, this information is derived from direct imaging of the patient, not from testing samples taken from the patient.
- The device description details the imaging modes and display of ultrasound data. This aligns with the function of an in-vivo imaging system, not an in-vitro diagnostic device.
Therefore, the S3000™ ultrasound imaging system falls under the category of a medical imaging device used for in-vivo diagnosis, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The S3000™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, 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, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information 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 Ultrsound 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.
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, OBJ
Device Description
The S3000™ Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, Intra-cardiac, Intra-luminal, Great Vessel
Indicated Patient Age Range
Adult and Pediatric (for Acuson Acunav Ultrasound Catheter)
Intended User / Care Setting
Clinician, Physician
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)
Since the S3000 uses the same technology and principles as existing devices, clinical data is not required.
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.
K111674, K093812, K090334, K072786, K081148, K063085, K071234
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
MAY 1 7 2012
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Siemens Medical Solutions, Inc. Ultrasound Division
S3000 Ultrasound System 510(k) Submission
510(k) Summarv Prepared March 19, 2012
- Sponsor:
Siemens Medical Solutions, Inc., Ultrasound Division 1230 Shorebird Way Mountain View, California 94043
Contact Person:
Shelly Pearce Telephone: (650) 694-5988 Fax: (650) 694-5580
- Device Name: Acuson S3000™ Diagnostic Ultrasound System
Diagnostic Ultrasound System Common Name:
Classification:
Regulatory Class: = Review Category: Tier II Classification Panel: Radiology
Ultrasonic Pulsed Doppler Imaging System FR # 892.1550 Product Code 90-IYN Ultrasonic Pulsed Echo Imaging System FR # 892.1560 Product Code 90-IYO Diagnostic Ultrasound Transducer FR # 892.1570 Product Code 90-ITX Diagnostic Ultrasound Catheter FR # 870.1200 Product Code OBJ
3. Legally Marketed Predicate Devices
The Acuson S3000™Ultrasound System is substantially equivalent to the company's own Acuson Antares and S2000 Ultrasound Systems.
4. Device Description:
The S3000™ Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display. It is substantially equivalent to our current S2000 product (K111674, K093812, K090334, K072786, K081148), and Siemens V7M (K063085), AcuNav 8F and AcuNav 10F (K071234) transducers. These predicates are legally marketed devices.
5. Intended Use
The S3000™ ultrasound imaging systems are intended for the following applications: Fetal. Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
1
The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information 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 Ultrsound 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.
| Feature / Characteristic | Acuson S3000 | Acuson S2000 K072786 | Acuson S2000 K093812 | Acuson S2000 K090334 | Acuson S2000 K111674 |
|---|---|---|---|---|---|
| Indications for Use: | |||||
| ■ Fetal | √ | √ | √ | √ | √ |
| ■ Abdominal | √ | √ | √ | √ | √ |
| ■ Intraoperative abdominal and vascular | √ | √ | √ | √ | √ |
| ■ Intraoperative neurological | - | - | - | - | - |
| ■ Pediatric | √ | √ | √ | √ | √ |
| ■ Small Organ | √ | √ | √ | √ | √ |
| ■ Neonatal cephalic | √ | √ | √ | √ | √ |
| ■ Adult Cephalic | √ | √ | √ | √ | √ |
| ■ Cardiac | √ | √ | √ | √ | √ |
| ■ Trans-esophageal | √ | √ | √ | √ | √ |
| ■ Transrectal | √ | √ | √ | √ | √ |
| ■ Transvaginal | √ | √ | √ | √ | √ |
| ■ Peripheral vessel | √ | √ | √ | √ | √ |
| ■ Laparoscopic | - | - | - | - | - |
| ■ Musculo-skeletal (conventional) | √ | √ | √ | √ | √ |
| ■ Musculo-skeletal (superficial) | √ | √ | √ | √ | √ |
| Center Frequencies Supported: | |||||
| ■ 2.0 MHz | √ | √ | √ | √ | √ |
| ■ 3.0 MHz | √ | √ | √ | √ | √ |
| ■ 3.2 MHz | √ | √ | √ | √ | √ |
| ■ 3.3 MHz | √ | √ | √ | √ | √ |
| ■ 4.2 MHz | √ | √ | √ | √ | √ |
| Feature / Characteristic | Acuson S3000 | Acuson S2000 K072786 | Acuson S2000 K093812 | Acuson S2000 K090334 | Acuson S2000 K111674 |
| 4.4 MHz | √ | √ | √ | √ | √ |
| 4.8 MHz | √ | √ | √ | √ | √ |
| 5.0 MHz | √ | √ | √ | √ | √ |
| 5.2 MHz | √ | √ | √ | √ | √ |
| 6.0 MHz | √ | √ | √ | √ | √ |
| 6.5 MHz | √ | √ | √ | √ | √ |
| 6.9 MHz | √ | √ | √ | √ | √ |
| 9.5 MHz | √ | √ | √ | √ | √ |
| 10.0 MHz | √ | √ | √ | √ | √ |
| Modes: | |||||
| B | √ | √ | √ | √ | √ |
| Parallel processing in B mode | √ | √ | √ | √ | √ |
| M | √ | √ | √ | √ | √ |
| PWD (Pulsed Wave Doppler) | √ | √ | √ | √ | √ |
| CWD (Continuous Wave Doppler) | √ | √ | √ | √ | √ |
| D (Color Doppler) | √ | √ | √ | √ | √ |
| Amplitude Doppler | √ | √ | √ | √ | √ |
| Combined (BMDC) | √ | √ | √ | √ | √ |
| Features: | |||||
| Quad processing in color | √ | √ | |||
| Native TM tissue harmonic imaging | √ | √ | |||
| SieScape TM panoramic imaging | √ | √ | |||
| Color SieScape TM panoramic imaging | √ | √ | |||
| 3-Scape TM real-time 3D imaging | √ | √ | |||
| fourSight TM 4D transducer technology | √ | √ | |||
| TEQ TM ultrasound technology | √ | √ | |||
| Cardiac Imaging physiological signal display | √ | √ | |||
| syngo ® Auto OB measurements | √ | √ | |||
| Advanced SieClear TM spatial compounding | √ | √ | |||
| STIC | √ | √ | |||
| Amnioscopic rendering | √ | √ | |||
| Cadence contrast agent imaging | √ | √ | |||
| Clarify TM vascular enhancement technology | √ | √ | |||
| eSie TM Touch elasticity imaging | √ | √ | |||
| syngo® Auto Left heart | √ | √ | |||
| syngo ® Velocity Vector Imaging | √ | √ | |||
| Semi Auto-segmentation | √ | √ | |||
| Custom Tissue Imaging / Speed of Sound | √ | √ | |||
| AHP | √ | √ | |||
| Monitor: 19" FPD | √ | √ | |||
| Feature / Characteristic | Acuson | ||||
| S3000 | Acuson | ||||
| S2000 | |||||
| K072786 | Acuson | ||||
| S2000 | |||||
| K093812 | Acuson | ||||
| S2000 | |||||
| K090334 | Acuson | ||||
| S2000 | |||||
| K111674 | |||||
| Patient Contact Materials . | Tested to ISO | ||||
| 10993-1 | Tested to ISO | ||||
| 10993-1 | Tested to ISO | ||||
| 10993-1 | Tested to ISO | ||||
| 10993-1 | Tested to ISO | ||||
| 10993-1 | |||||
| UL 60601-1 Certified | √ | √ | √ | √ | √ |
6. Summary of Technological Characteristics - New Device Compared to Predicate
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7. A brief discussion of nonclinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence.
The device has been evaluated for acqustic output, biocompatibility, cleaning and disinfection, effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The system complies with the following voluntary standards:
- UL 60601-1, Safety Requirements for Medical Equipment .
- IEC 60601-2-37 Diagnostic Ultrasound Safety Standards "
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment .
- AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical 트 Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 트 AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
- 93/42/EEC Medical Devices Directive ■
- Safety and EMC Requirements for Medical Equipment 체
- . EN/IEC 60601-1
- . EN/IEC 60601-1-1
- EN/IEC 60601-1-2 I
- IEC 1157 Declaration of Acoustic Power ■
- ISO 10993-1 Biocompatibility I
Cleared patient contact materials, electrical and mechanical safety are unchanged.
8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.
Since the S3000 uses the same technology and principles as existing devices, clinical data is not required.
9. Summary
Intended uses and other key features are consistent with traditional clinical practice and FDA quidelines. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Requlation and ISO 13485:2003 quality system standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore it is the opinion of Siemens Medical that the S3000 is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings. The overall design is simple and conveys a sense of official government branding.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Siemens Medical Solutions USA, Inc. % Mr. Mark Job Third Party Consultant Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
MAY 1 7 2012
Re: K121138
Trade/Device Name: S3000TM Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: May 10, 2012 Received: May 14, 2012
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
This determination of substantial equivalence applies to the following transducers intended for use with the S3000™ Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
CW2 Probe CW5 Probe EC9-4 Curved Array 9L4 Linear Array 14L5 Multi-D Array 4P1 Phased Array 6C2 Curved Array
4C1 Curved Array 6C1HD Curved Array 8C3HD Curved Array 4V1 Phased Array 10V4 Phased Array 14L5 SP Linear Array 7CF2 Curved array mechanical 3D
5
9EVF4 Curved Array V5Ms Multiplane TEE 18L6 HD Linear Array 8V3 Phased Array 4V1c Phased Array
રા રે -EV8C4 V7M TEE AcuNav 8F Ultrasound Catheter AcuNay 10F Ultrasound Catheter
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Jeffrey J. Ballyns at (301) 796-6105.
Sincerely Yours.
Andres D'Okon for
Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
6
S3000 Ultrasound System 510(k) Submission
1.3 Indications for Use
A. 510(k) Number (if known):
Device Name: S3000™Diagnostic Ultrasound System
Indications for Use: ·
The S3000™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, 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, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information 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 Ultrsound 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.
Prescription Use × (Part 21CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Arunl Doth
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 6121138
Page 1 of
S3000 510(k) Submission
Page 14 of 59
7
1.3 Indications for Use Forms
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name:
ACUSON S3000 Ultrasound System
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 | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, | ||
| 11, 13 | ||||||||||
| Abdominal | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, | ||
| 11, 13, 16 | ||||||||||
| Intraoperative | ||||||||||
| (Note 9) | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, | ||
| 11, 14 | ||||||||||
| Intraoperative | ||||||||||
| Neurological | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, | ||
| 11, 14 | ||||||||||
| Pediatric | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, | ||
| 11 | ||||||||||
| Small Organ | ||||||||||
| (Note 1) | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, | ||
| 11,14, 16 | ||||||||||
| Neonatal Cephalic | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10 | ||
| Adult Cephalic | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10 | ||
| Cardiac | N | N | N | N | N | N | BMDC | Note | ||
| 2,3,4,5,6,7,8,10,15 | ||||||||||
| Trans-esophageal | N | N | N | N | N | N | BMDC | Note 4 | ||
| Transrectal | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, | ||
| 11,14 | ||||||||||
| Transvaginal | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, | ||
| 11 | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6,7,8,10, | ||
| 11,14,15 | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, | ||
| 11,14 | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, | ||
| 11,14 | ||||||||||
| Other (specify) | ||||||||||
| Neonatal Cardiac | N | N | N | N | N | N | BMDC | Note 3,4,6, 10 |
N = new indication; P = previously cleared by FDA K063085, K072786, K081148, K092142, K090334, K111674
For example: breast; testes, thyroid, penis, prostate, etc. Note 1
Note 3 SieClear multi-view spatial compounding
3-Scape real-time 3D imaging Note 5
B&W SieScape panoramic imaging Note 7
Note 9 For example: vascular, abdominal
Note 11 Advanced Sieclear spatial compounding
eSie™ Touch elasticity imaging / FTI Note 14
Custom Tissue Imaging Note 16
| Note 4 | Tissue Equalization Technology |
|---|---|
| Note 6 | Cadence contrast agent imaging |
| Note 8 | Power SieScape panoramic imaging |
| Note 10 | Clarify VE vascular enhancement technology |
| Note 13 | STIC |
| Note 15 | AHP |
Note 2 Ensemble tissue harmonic imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRA, Office of In Vite Diagnostic Devices (OIVD) Prescription Use. Bart 1 OER 801 Submart D)
(Division Sign-Off) Bivision of Radiological Devices Offise of In Vitro Diagnostic Device Evaluation and Safety
| S3000 510(k) Submission | |
|---|---|
| -- | ------------------------- |
8
S3000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
CW2 Probe for use with ACUSON S3000
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 | ||||||||||
| (Note 9) | P | |||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | P | |||||||||
| Small Organ | ||||||||||
| (Note 1) | P | |||||||||
| 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 K# 063803; K072786, K081148, K082142, K111674
Additional Comments:
RIOK
For example: breast, testes, thyroid, penis, prostate, etc. Note 1 · Note 9 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Bign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
9
S3000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use: CW5 Probe for use with ACUSON S3000
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 | ||||||||||
| (Note 9) | P | |||||||||
| Intraoperative | ||||||||||
| Neurological | P | |||||||||
| Pediatric | P | |||||||||
| Small Organ | ||||||||||
| (Note 1) | P | |||||||||
| Neonatal Cephalic | P | |||||||||
| Adult Cephalic | P | |||||||||
| Cardiac | P | |||||||||
| Trans-esophageal | ||||||||||
| Transrectal | i . | |||||||||
| 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 K# 063803, K072786, K081148, K082142, K111674
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note a For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)
(Division Sign-Off)
Division of Radiological Device: Evaluation and Sefat
Office of In Vitro Diagnostic Device Evaluation and Safety
510K: K121138
10
S3000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
EC9-4 Curved Array Transducer for use with ACUSON S3000 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 | Note 2,3,4,5,7,8,10, 11 | |||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,5,6,7,8,10, 11, | |||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, 11,14 | |||
| Neonatal Cephalic | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10 | |||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | P | P | P | P | P | BMDC | Note 2,3,4,5, 6, 7,8,10, | |||
| 11,14 | ||||||||||
| Transvaginal | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, 11 | |||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063803, K072786, K081148, K082142, K111674
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 2 Ensemble tissue harmonic imaging
SieClear multi-view spatial compounding Note 3
Tissue Equalization Technology Note 4
3-Scape real-time 3D imaging Note 5
Note 6 Cadence contrast agent imaging
Note 7 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 8
Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding
Note 14 eSie™ Touch elasticity imaging / FT1
(PLEASE DO NOT W
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Division of RadiologicalDomagarrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Office of In Vito Diagnosic Device Evauation and Safescription Use (Part 21CFR 801 Subpart D)
510K. Klaii38
S3000 510{k) Submission
11
S3000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
9L4 Linear Array Transducer for use with ACUSON S3000 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 | Note 2,3,4,5,7,8,10, 11 | |||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, 11 | |||
| Small Organ | ||||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,5,6,7,8,10, 11,14, | |||
| 16 | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, 11 | |||
| Adult Cephalic | P | P | P | P | P | |||||
| Cardiac | P | P | P | P | P | BMDC | Note 15 | |||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,5,6,7,8,10, 11, | |||
| 14,15 | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | P | P | P | P | P | BMDC | Note 2,3,4,5,6,7,8,10, 11, 14 | |||
| Musculo-skeletal | ||||||||||
| Superficial | P | P | P | P | P | BMDC | Note 2,3,4,5,6,7,8,10, 11, 14 | |||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K090334, K093812, K111674
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
- Note 2 Ensemble tissue harmonic imaging
- Note 3 SieClear multi-view spatial compounding
- Note 4 Tissue Equalization Technology
- Note 5 3-Scape real-time 3D imaging
- Note 6 Cadence contrast agent imaging
- Note 7 B&W SieScape panoramic imaging
- Note 8 Power SieScape panoramic imaging Note 10 Clarify VE vascular enhancement technology
- Note 11 Advanced Sieclear spatial compounding
- Note 14 eSie™ Touch elasticity imaging / FTI
- Note 15 AHP
Note 16 Custom Tissue Imaging
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K121138
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
12
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
14L5 Multi-D Array Transducer for use with ACUSON S3000 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 | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | ||||
| 11, 14, 16 | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,5,6, | ||||
| 7,8,10, 11, 14 | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | ||||
| 11, 14 | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K090334, K093812, K111674
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
- Ensemble tissue harmonic imaging Note 2
- Note 3 SieClear multi-view spatial compounding
- Note 4 Tissue Equalization Technology
- Note 5 3-Scape real-time 3D imaging
- Cadence contrast agent imaging Note 6
- Note 7 B&W SieScape panoramic imaging
- Power SieScape panoramic imaging Note 8 Note 10 Clarify VE vascular enhancement technology
- Advanced Sieclear spatial compounding
- Note 11 eSie™ Touch elasticity imaging / FTI Note 14
- Note 16 Custom Tissue Imaging
Mum D. O'the
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety ElOK
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13
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if.known):
Device Name: Intended Use:
4P1 Phased Array Transducer for use with ACUSON S3000 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 | Note 2,3,4,5,7,8,10 | ||
| Abdominal | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10 | ||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10 | ||
| Cardiac | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6,7,8,10 | ||
| 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 K# 063803, K072786, K081148, K090334, K093812, K111674
Additional Comments:
Ensemble tissue harmonic imaging Note 2
Note 3 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 4
Note 5 3-Scape real-time 3D imaging
Cadence contrast agent imaging Note 6
B&W SieScape panoramic imaging Note 7
Power SieScape panoramic imaging Note 8
Note 10 Clarify VE vascular enhancement technology
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)
Pre
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K
K121/38
S3000 510(k) Submission
14
S3000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
6C2 Curved Array Transducer for use with ACUSON $3000 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 | Note 2,3,4,5,7,8,10, | ||||
| 11 | |||||||||||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | ||||
| 11, 14, 16 | |||||||||||
| Intraoperative | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | ||||
| 11 | |||||||||||
| Small Organ | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | ||||
| 11 | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K080334, K093812, K111674
Additional Comments:
Note 2 Ensemble tissue harmonic imaging
SieClear multi-view spatial compounding Note 3
Tissue Equalization Technology Note 4
3-Scape real-time 3D imaging Note 5
Note 7 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 8
Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding
Note 14 eSie™ Touch elasticity imaging / FTI
Note 16 Custom Tissue Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Ot) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division of Radiological Devices Prescription Use (Part 21CFR 801 Subpart D)
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K12138
S3000 510(k) Submission
15
S3000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
- 510 (k) Number (if known):
Device Name: Intended Use:
4C1 Curved Array Transducer for use with ACUSON S3000 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 | Note 2,3,4,5,7,8,10, | |||
| 11 | |||||||||||
| Abdominal | P | P | P | P | P | P | BMDC | Note2,3,4,5,6,7,8, | |||
| 10, 11, 14, 16 | |||||||||||
| Intraoperative | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | P | P | P | P | P | P | BMDC | ||||
| 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 K# 063085, K072786, K081148, K090334, K093812, K111674
Additional Comments:
Note 2 Ensemble tissue harmonic imaging
- Note 3 SieClear multi-view spatial compounding
- Note 4 Tissue Equalization Technology
- 3-Scape real-time 3D imaging Note 5
- Note 6 Cadence contrast agent imaging Note 7 B&W SieScape panoramic imaging
- Power SieScape panoramic imaging Note 8
- Clarify VE vascular enhancement technology Note 10
Note 10 Clarity VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding
- Note 14 eSie™ Touch elasticity imaging / FTI
- Note 16 Custom Tissue Imaging
Note 16 Custom Tissue Imaging
(Division Sign-Off)
Division of Radiological Devices
Division of Radiological Devices Office of In Evaluation and Safety
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
16
S3000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
6C1HD Curved Array Transducer for use with ACUSON S3000 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 | Note 2,3,4,5,7,8,10, | ||
| 11 | ||||||||||
| Abdominal | P | P | P | P | P | P | BMDC | Note2,3,4,5,6,7,8, | ||
| 10, 11, 14, 16 | ||||||||||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | P | P | P | P | P | P | BMDC | |||
| 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 K# 111674
Additional Comments:
- Ensemble tissue harmonic imaging Note 2
- SieClear multi-view spatial compounding Note 3
- Tissue Equalization Technology Note 4
- 3-Scape real-time 3D imaging Note 5
- Cadence contrast agent imaging Note 6
- Note 7 B&W SieScape panoramic imaging Power SieScape panoramic imaging
- Note 8 Note 10 Clarify VE vascular enhancement technology
- Note 11 Advanced Sieclear spatial compounding Note 14 eSie™ Touch elasticity imaging / FTI
Note 16 Custom Tissue Imaging
(Division Sign-Off)
Division of Radiological Devices
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K121138
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
17
S3000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use: 8C3HD Curved Array Transducer for use with ACUSON S3000 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 | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, | |||
| 11 | ||||||||||
| Abdominal | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, | |||
| 11, 14, 16 | ||||||||||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, | |||
| 11 | ||||||||||
| Small Organ | N | N | N | N | N | BMDC | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | N | N | N. | N | N | BMDC | Note 2,3,4,5,7,8,10, | |||
| 11 | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K#
Additional Comments:
- Ensemble tissue harmonic imaging Note 2
- Note 3 SieClear multi-view spatial compounding
- Tissue Equalization Technology Note 4
- 3-Scape real-time 3D imaging Note 5
- Cadence contrast agent imaging Note 6
- Note 7 B&W SieScape panoramic imaging. Power SieScape panoramic imaging Note 8
- Note 10 Clarify VE vascular enhancement technology
- Advanced Sieclear spatial compounding Note 11
- eSie™ Touch elasticity imaging / FTI Note 14
- Note 16 Custom Tissue Imaging
(Division Sign-Off)
of Radiological Device tic Device Evaluation and Safety
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
રાજ્ય
18
S3000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
4V1 Phased Array Transducer for use with ACUSON S3000 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 | Note 2,3,4,5,7,8,10 | |||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||
| 14, 16 | ||||||||||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| 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 K# 063085, K072786, K081148, K090334, K093812, K111674
Additional Comments:
- Ensemble tissue harmonic imaging Note 2
- SieClear multi view spatial compounding Note 3
- Tissue Equalization Technology Note 4
- Note 5 3-Scape real-time 3D imaging .. .
- Note 7 B&W SieScape panoramic imaging Power SieScape panoramic imaging
- Note 8 Clarify VE vascular enhancement technologyfice of In Note 10
- Advanced Sieclear spatial compounding Note 11
- eSie™ Touch elasticity imaging / FTI Note 14
- Note 16 Custom Tissue Imaging
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
Klal38
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
510K
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)
S3000 510(k) Submission
Page 26 of 59
19
S3000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
10V4 Phased Array Transducer for use with ACUSON S3000 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 | Note 2,3,4,5,7,8,10 | |||
| Abdominal | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10 | |||
| Intraoperative | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10 | |||
| Small Organ | |||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10 | |||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | P | P | P | BMDC | Note 3,4 | |||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10 | |||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K090334, K093812, K111674
Additional Comments:
Note 2 Ensemble tissue harmonic imaging
Note 3 SieClear multi view spatial compounding
Tissue Equalization Technology Note 4
Note 5 3-Scape real-time 3D imaging
B&W SieScape panoramic imaging Note 7
Note 8 Power SieScape panoramic imaging
Clarify VE vascular enhancement technology Note 10
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K121138
S3000 510(k) Submission
Page 27 of 59
20
S3000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Indications For Use: 14L5 SP Linear Array Transducer for use with ACUSON $3000 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 | ||||||||||||
| (Note 9) | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10 | |||||
| Intraoperative | ||||||||||||
| Neurological | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||||
| 11 | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ | ||||||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||||
| 11,14, 16 | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | P | P | P | P | P | BMDC | Note 15 | |||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note2,3,4,5,6, | |||||
| 7,8,10, 11,14,15 | ||||||||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Conventional | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||||
| 11,14 | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Superficial | ||||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K090334, K111674
Additional Comments: -
- For example: breast, testes, thyroid, penis, prostate, etc. Note 1
- Ensemble tissue harmonic imaging Note 2
- SieClear multi-view spatial compounding Note 3
- Tissue Equalization Technology Note 4
- Note 5 3-Scape real-time 3D imaging
- Cadence contrast agent imaging Note 6
- B&W SieScape panoramic imaging Note 7
- Note 8 Power SieScape panoramic imaging
- For example: vascular, abdominal Note 9
- Note 10 Clarify VE vascular enhancement technology
- Advanced Sieclear spatial compounding Note 11
- Note 14 eSie™ Touch elasticity imaging / FTI
Note 15 AHP Note 16 Custom Tissue Imaging
A. A. D'Ohm
(Division Sion-Off Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
21
S3000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
7CF2 Curved array mechanical 3D transducer for use with ACUSON S3000 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 | Note 2,3,4,5,7,8,10, | |||
| 11,13 | ||||||||||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||
| 11, 13 | ||||||||||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| 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 K# 063803, K072786, K081148, K090334, K093812, K111674
Additional Comments:
- Ensemble tissue harmonic imaging Note 2
- Note 3 SieClear multi-view spatial compounding
- Note 4 Tissue Equalization Technology
- Note 5 3-Scape real-time 3D imaging Note 7 B&W SieScape panoramic imaging
- Note 8 Power SieScape panoramic imaging Note 10 Clarify VE vascular enhancement technology
- Note 11 Advanced Sieclear spatial compounding
- Note 13 STIC
(Division Sign-Off)
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Office of In Vitro Diagnostic Device Evaluation and Safety
151138
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22
30 of 3658
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
9EVF4 Curved Array Transducer for use with ACUSON S3000 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 | Note 2,3,4,5,7,8, | |||
| 10,11, 13 | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8, | |||
| 10,11 | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8, | |||
| 10,11 | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063803, K072786, K081148, K080334, K093812, K111674
Additional Comments:
Ensemble tissue harmonic imaging Note 2
SieClear multi-view spatial compounding Note 3
Tissue Equalization Technology Note 4
3-Scape real-time 3D imaging Note 5
Note 7 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 8
- Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding
Note 13 STIC
(Division Sign-Off)
Division of Radiological Devices
Office of In tic Device Evaluation and Safet
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510K
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)
S3000 510(k) Submission
23
S3000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
V.5Ms Multiplane TEE Transducer for use with ACUSON S3000 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 | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | P | P | P | P | P | P | P | BMDC | Note 4 | |
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063803, K072786, K081148, K080334, K093812, K111674
Additional Comments: Tissue Equalization Technology Note 4
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D) Chom Blanch
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K121138
24
$3000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
18L6 HD Linear Array Transducer for use with ACUSON S3000 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 | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||
| 11,14, 16 | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | BMDC | Note 15 | |||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||
| 11,14,15 | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||
| 11,14 | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||
| 11,14 | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K081148, K082142, K090334, K093812, K111674
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 2 Ensemble tissue harmonic imaging
SieClear multi-view spatial compounding Note 3
Tissue Equalization Technology Note 4
3-Scape real-time 3D imaging Note 5
B&W SieScape panoramic imaging Note 7
Note 8 Power SieScape panoramic imaging
Clarify VE vascular enhancement technology Note 10
Note 11 Advanced Sieclear spatial compounding
Note 14 eSie™ Touch elasticity imaging / FTI
Note 16 Custom Tissue Imaging
Note 15 AHP
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K12138
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
25
S3000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known): ·
Device Name: Intended Use:
8V3 Phased Array Transducer for use with ACUSON S3000 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 | Note 2,3,4,5,7,8,10 | ||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10 | ||
| Small Organ | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10 | ||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | P | BMDC | Note 3,4,6 | ||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | P | |||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) | ||||||||||
| Neonatal Cardiac | P | P | P | P | P | P | BMDC | Note 3,4,6 |
N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K082142, K111674
Additional Comments:
Note 2 Ensemble tissue harmonic imaqing
SieClear multi-view spatial compounding Note 3
Tissue Equalization Technology Note 4
3-Scape real-time 3D imaging Note 5
Cadence contrast agent imaging Note 6
Note 7 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 8
Note 10 Clarify VE vascular enhancement technology
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription Use (Part 21CFR 801 Subpart D) sion Sign-Off
Division of Radiological Devices Office of in Vitro Device Evaluation and Safety
S3000 510(k) Submission
રાભર
26
S3000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
4V1c Phased Array Transducer for use with ACUSON S3000 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 | Note 2 3 4 5 7 8 10 | |||
| Abdominal | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10 | |||
| Intraoperative | |||||||||||
| Abdominal | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10 | |||
| Intraoperative | |||||||||||
| Neurological | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10 | |||
| Pediatric | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10 | |||
| Small Organ | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10 | |||
| Cardiac | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10 | |||
| 15 | |||||||||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10 | |||
| 15 | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) | |||||||||||
| Neonatal Cardiac | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10 |
N = new indication; P = previously cleared by FDA K#'s 052410, 051139, 041319, 032114, 022567; 063085, K090334, K093812, K111674
Additional Comments:
- Ensemble tissue harmonic imaging Note 2
- SieClear multi-view spatial compounding Note 3
- Note 4 Tissue Equalization Technology
- 3-Scape real-time 3D imaging Note 5
- Cadence contrast agent imaging Note 6
- B&W SieScape panoramic imaging Note 7
- Note 8 Power SieScape panoramic imaging
- Note 10 Clarify VE vascular enhancement technology
- Note 15 AHP .
(Division Sign-Off)
Division of Radiological Devices Office of In itro Diago tic Device Evaluation and Safety 510K
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
27
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
6L3 Transducer for use with ACUSON S3000 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 | Note 2 3 4 5 7 8 10, | ||
| 11 | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Abdominal | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10, | ||
| 11 | ||||||||||
| Intraoperative | ||||||||||
| Neurological | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10, | ||
| 11 | ||||||||||
| Pediatric | ||||||||||
| Small Organ | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10, | ||
| 1 | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10 | ||
| 15 | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10, | ||
| 11 15 | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10, | ||
| 11 | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10, | ||
| 11 | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K#'s 052410, 051139, 041319, 032114, 022567, 002807, 973767, 063085, K090334, K093812, K111674
Additional Comments:
-
Ensemble tissue harmonic imaging Note 2
Note 3 SieClear multi-view spatial compounding -
Tissue Equalization Technology Note 4
-
3-Scape real-time 3D imaging Note 5
-
Note 6 Cadence contrast agent imaging
Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic imaging
- Note 10 Clarify VE vascular enhancement technology Advanced Sieclear spatial compounding Note 11
- Note 15 AHP
(Division Sign-Off)
Division of Radiological Devic Office of In agnostic Device Evaluation and Sa
510K 5101138
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
28
S3000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
EV8C4 Transducer for use with ACUSON S3000 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 | Note 2 3 4 5 7 8 10 | ||
| Abdominal | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10 | ||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | P | P | P | P | P | P | BMDC | Note 2 3 4 5 6 7 8 | ||
| 10 | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletai | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K#'s 052410, 051139, 041319, 032114, 022567, 002807, 973767, 063085, K090334, K093812, K111674
Additional Comments:
Ensemble tissue harmonic imaging Note 2
SieClear multi-view spatial compounding Note 3
Note 4 Tissue Equalization Technology
Note 5 3-Scape real-time 3D imaging
Cadence contrast agent imaging Note 6
B&W SieScape panoramic imaging Note 7
Power SieScape panoramic imaging Note 8
Note 10 Clarify VE vascular enhancement technology 510K
(Division Sign-Off)
Division of Radiological Devices
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
K121138
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)
S3000 510(k) Submission
Page 36 of 59
29
S3000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
V7M TEE Transducer for use with ACUSON S3000 Ultrasound imaging or fluid flow analysis of the human body as follows:
| 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 | Note 4 |
| Intraoperative
Abdominal | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P | P | Note 4 |
| Small Organ
(specify) ** | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P | P | Note 4 |
| Trans-esophageal | | P | P | P | P | P | P | | P | P | Note 4 |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
P=previously cleared by the FDA under premarket notifications #K052410, #K051139, #K032114, and #K022567, K093812, K111674
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
Note 2 Ensemble tissue harmonic imaging
Note 4 Tissue Equalization Technology
Note 10 Clarify VE vascular enhancement technology
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
SION
30
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
AcuNav 8F Ultrasound Catheter for use with ACUSON S3000 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 | ||||||||||
| Ophtalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| (Vascular) | ||||||||||
| Intraoperative | ||||||||||
| (Neurological) | ||||||||||
| Pediatric | P | P | P | P | P | P | P | |||
| Small Organ | ||||||||||
| (Specify)** | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | P | P | |||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intra-Luminal | 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=Previously cleared by the FDA K992631, K033650, K042593, K071234, K093812, K111674
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 ANOTHER PAGE IF NEEDED)
oncurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)
Division of Radiological Devices Office of In Device Evalyation and Serie y ਹੈ। ਹੈਲ
S3000 510(k) Submission
31
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
.
AcuNav 10F Ultrasound Catheter for use with ACUSON $3000 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 | |||||||||||
| Ophtalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| (Vascular) | |||||||||||
| Intraoperative | |||||||||||
| (Neurological) | |||||||||||
| Pediatric | P | P | P | P | P | P | P | ||||
| Small Organ | |||||||||||
| (Specify)** | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | P | P | P | P | ||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intra-Luminal | 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=Previously cleared by the FDA K992631, K033650, K042593, K071234, K093812, K111674
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 ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) | |
|---|---|
| Prescription Use (Part 21CFR 801 Subpart D) | |
| (Division Sign-Off) | |
| Division of Radiological Devices | |
| Office of In Vitro Diagnostic Device Evaluation and Safety | |
| 510K |