(15 days)
The S2000™ 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.
The S2000™ 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. 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.
The Siemens Acuson S2000 Ultrasound System (K111674) is a diagnostic ultrasound system. As a 510(k) submission, the device demonstrates substantial equivalence to predicate devices, meaning it does not require new clinical studies to prove safety and effectiveness. Therefore, the information typically requested regarding acceptance criteria and separate efficacy studies is not applicable in the same way as it would be for a novel device.
The submission primarily focuses on demonstrating that the modified Acuson S2000 Ultrasound System has equivalent technological characteristics and intended uses to existing cleared devices (Acuson Antares and other S2000 systems).
Here's a breakdown of the relevant information from the provided text:
1. Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission for substantial equivalence based on
existing technology, the "acceptance criteria" are primarily met through comparisons to predicate devices and adherence to recognized safety and performance standards. There isn't a specific "device performance" section with metrics in the format of a clinical trial. Instead, performance is implied to be equivalent to the predicate devices.
The table below summarizes characteristics and their equivalence to predicate devices:
| Feature / Characteristic | Acuson S2000 (New Device) | Acuson Antares (Predicate K# 063803) |
|---|---|---|
| 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 | √ | √ |
| 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) | √ | √ |
| Output Display Standard (Track 3) | √ | √ |
| Patient Contact Materials | Tested to ISO 10993-1 | Tested to ISO 10993-1 |
| UL 60601-1 Certified | √ | √ |
Key Acceptance Criteria (as per 510(k) process):
- Substantial Equivalence: The primary acceptance criterion for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness.
- Adherence to Standards: Compliance with recognized national and international safety and performance standards (e.g., UL 60601-1, IEC 60601-2-37, ISO 10993-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2).
- Biocompatibility: Patient contact materials meet ISO 10993-1.
- Safety: Evaluation for acoustic output, thermal, electrical, electromagnetic, and mechanical safety.
- Cleaning and Disinfection: Effectiveness demonstrated.
2. Sample Size Used for the Test Set and Data Provenance
The provided document states: "Since the S2000 uses the same technology and principles as existing devices, clinical data is not required." This indicates that no specific clinical test set data was generated or used for this 510(k) submission to demonstrate new performance or efficacy. The substantial equivalence argument relies on the established performance and safety of the predicate devices and the technical verification of the modified device. Therefore, information on sample size, data provenance (country of origin, retrospective/prospective) for a test set, expert ground truthing, or adjudication methods is not directly applicable to this type of submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable (see point 2).
4. Adjudication Method for the Test Set
Not applicable (see point 2).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not performed or presented as part of this 510(k) submission. The submission is not designed to prove improvement with or without AI assistance, as it's a re-clearance/modification of an existing diagnostic ultrasound system based on substantial equivalence.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not performed or presented. This device is a diagnostic ultrasound system operated by a human clinician, not a standalone AI algorithm.
7. Type of Ground Truth Used
Not applicable, as no new clinical studies were conducted for efficacy. The "ground truth" for the predicate devices would have been established through methodologies typical for diagnostic ultrasound validation at the time of their original clearance (e.g., correlation with clinical outcomes, expert interpretation, pathology, or other imaging modalities), but this is not detailed for this specific submission.
8. Sample Size for the Training Set
Not applicable. There is no mention of a "training set" in the context of an AI/ML algorithm. This submission describes a hardware and software system, not an AI model requiring a training set in the modern sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable (see point 8).
In summary: The K111674 submission for the Siemens Acuson S2000 Ultrasound System demonstrates substantial equivalence to predicate devices. This means that extensive new clinical acceptance criteria studies, including test sets, ground truth establishment by experts, or AI-specific performance metrics (like MRMC or standalone performance), were not required or presented. The primary "study" is the comparison against technical specifications and intended uses of already cleared devices, and adherence to relevant safety and performance standards.
{0}------------------------------------------------
JUN 3 0 2011
Siemens Medical Solutions, Inc. Ultrasound Division
S2000 Ultrasound System 510(k) Submission . .
510(k) Summarv Prepared May 12, 2011
| 1. Sponsor: | Siemens Medical Solutions, Inc.,Ultrasound Division1230 Shorebird WayMountain View, California 94043 |
|---|---|
| Contact Person: | Shelly PearceTelephone: (650) 694-5988Fax: (650) 694-5580 |
| Submission Date: | May 12, 2011 |
| 2. Device Name: | Acuson S2000™ Diagnostic Ultrasound System |
| Common Name: | Diagnostic Ultrasound System |
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 modified Acuson S2000™Ultrasound System is substantially equivalent to the the company's own Acuson Antares and S2000 Ultrasound Systems.
4. Device Description:
The S2000™ 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. 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 (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 S2000™ 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 ffetal, 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 | AcusonS2000 | AcusonAntaresK# 063803 | |
|---|---|---|---|
| Indications for Use: | |||
| ■ | Fetal | √ | √ |
| ■ | Abdominal | √ | √ |
| ■ | Intraoperative abdominal andvascular | √ | √ |
| ■ | 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 | √ | √ |
6. Summary of Technological Characteristics - New Device Compared to Predicate
{2}------------------------------------------------
S2000 Ultrasound System 510(k) Submission
| Feature / Characteristic | AcusonS2000 | AcusonAntaresK# 063803 |
|---|---|---|
| 4.2 MHz | √ | √ |
| 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) | √ | √ |
| Output Display Standard (Track 3) | √ | √ |
| Patient Contact Materials | Tested to ISO10993-1 | Tested to ISO10993-1 |
| UL 60601-1 Certified | √ | √ |
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 acoustic 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 D
- I 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 . Acoustic Output Indices on Diagnostic Ultrasound Equipment
-
AIUM/NEMA UD-2. Acoustic Output Measurement Standard for Diagnostic Ultrasound
- . 93/42/EEC Medical Devices Directive
- Safety and EMC Requirements for Medical Equipment .
- =
- EN/IEC 60601-1-1 .
- EN/IEC 60601-1-2 .
- . IEC 1157 Declaration of Acoustic Power
- ISO 10993-1 Biocompatibility
Cleared patient contact materials, electrical and mechanical safety are unchanged.
{3}------------------------------------------------
8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.
Since the S2000 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 guidelines. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation 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 S2000 is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, with three curved lines forming its body and wings. The bird is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Druq Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Siemens Medical Solutions USA, Inc. Ultrasound Group % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K111674
Trade/Device Name: S2000" Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX and OBJ Dated: June 14, 2011 Received: June 15, 2011
JUN 3 0 2011
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 S2000" Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
CW2 CWS EC9-4 Curved Array 91_4 Linear Array 14L5 Multi-D Array 14L5BV Multi-D Array 4P1 Phased Array 6C2 Curved Array 4C1 Curved Array
6C1HD Curved Array 4V1 Phased Array 10V4 Phased Array 14L5 SP Linear Array 7CF2 Curved Array Mechanical 3D 9EVF4 Curved Array V5Ms Multiplane TEE 17LSHDS Linear Array 18L6 HD Linear Array
{5}------------------------------------------------
| 8V3 Phased Array | V7M TEE |
|---|---|
| 4V1c Phased Array | AcuNav 8F Ultrasound Catheter |
| 6L3 | AcuNav 10F Ultrasound Catheter |
| EV9C4 |
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/CDRH/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 Shahram Vaezy at (301) 796-6242.
Sincerely Yours.
Mary Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
{6}------------------------------------------------
1.3 Indications for Use
A. 510(k) Number (if known):
Device Name: S2000™Diagnostic Ultrasound System
Indications for Use:
The S2000™ 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 fool for communicating with patients reqarding 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)
Mary S. Pastel
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 1674
Page 1 of
S2000 510(k) Submission
Page 14 of 55
{7}------------------------------------------------
S2000 Ultrasound System 510(k) Submission
1.3 Indications for Use Forms
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name:
ACUSON S2000 Ultrasound System
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation Color Color Amplitude Other Combined PWD Clinical Application A B M CWD Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic P P P P P P Note 2,3,4,5,7,8,10, Fetal BMDC 11, 13 P p P P P P Note 2,3,4,5,7,8,10, Abdominal BMDC 11, 13, 16 P p P P P P Intraoperative Note 2,3,4,5,7,8,10, BMDC (Note 9) 11, 14 Intraoperative P P P P P Note 2,3,4,5,7,8,10, BMDC Neurological 11. 14 P p P P P Note 2,3,4,5,7,8,10, P Pediatric BMDC 11 P P Small Organ P P P P Note 2,3,4,5,7,8,10, BMDC (Note 1) 11,14, 16 P P P P P Neonatal Cephalic P BMDC Note 2,3,4,5,7,8,10 Adult Cephalic P P P p P P BMDC Note 2,3,4,5,7,8,10 P P P P P P Note Cardiac BMDC 2.3.4.5.6.7.8.10,15 P P P P P P Trans-esophageal BMDC Note 4 P ロ P P Note 2,3,4,5,7,8,10, P Transrectal BMDC 11.14 P P P P Note 2,3,4,5,7,8,10, P Transvaginal BMDC 11 Transurethral Intravascular P P P Note2,3,4,5,6,7,8,10, P P P Perioheral vessel BMDC 11,14,15 Laparoscopic Musculo-skeletal P P P P P P Note 2,3,4,5,7,8,10, BMDC Conventional 11,14 Musculo-skeletal P P P P Note 2,3,4,5,7,8,10, P p BMDC Superficial 11,14 Other (specify) P P P P P P Note 3,4,6, 10 BMDC Neonatal Cardiac
N = new Indication: P = previously cleared by FDA K063085, K063803, K072786, K081148, K082812
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
- Note 5 3-Scape real-time 3D imaging
B&W SieScape panoramic imaging Note 7
Note 9 For example: vascular, abdominal
Note 11 Advanced Sieclear spatial compounding
Note 14 eSie™ Touch elasticity imaging / FTI
- Note 16 Custom Tissue Imaging
Note 2 Ensemble tissue harmonic imaging 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
(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) |
Mary Stade
510K
S2000 510(k) Submission
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
SieClear multi-view spatial compounding Note 3
{8}------------------------------------------------
S2000 Ultrasound System 510{k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
CW2 Probe for use with ACUSON S2000
NL Probe for use with ACUSON S2000
Ultrasound imaging or fluid flow analysis of the human body
Device Name: Ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use: Mode of Operation Color Color Amplitude Combined Other B PWD CWD Clinical Application A M Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic P Felal Abdominal P Intraoperative P (Note 9) Intraoperative Neurological Pediatric P Small Organ P {Note 1) P Neonatal Cephalic Adult Cephalic P Cardiac P Trans-esophageal Transrectal Transvaglnal Transurethral Intravascular Peripheral vessel P Laparoscopic Musculo-skeletal P Conventional Musculo-skeletal P Superficial Other (specify)
N = new indication; P = previously cleared by FDA K# 063803, K072786, K081148, K082142, K093812
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 9 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)
Mary Slastel
Division of Radiological Devic Office of In Vitro Diagnostic Device Evaluation and Safety
K111674
510K
{9}------------------------------------------------
S2000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
CW5 Probe for use with ACUSON S2000
Device Name: 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 | P | |||||||||
| Abdominal | P | |||||||||
| Intraoperative(Note 9) | P | |||||||||
| IntraoperativeNeurological | ||||||||||
| 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-skeletalConventional | P | |||||||||
| Musculo-skeletalSuperficial | P | |||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063803, K072786, K081148, K082142, K090334, , K093812
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 9 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)
Mary Patel
Asion Sign-Off Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K111674
S2000 510(k) Submission
Page 18 of 56
.
{10}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
EC9-4 Curved Array Transducer for use with ACUSON S2000 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 | 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 | |||
| IntraoperativeAbdominal | ||||||||||
| IntraoperativeNeurological | ||||||||||
| 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-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063803, K072786, K081148, K092812
Additional Comments:
- Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
- Ensemble tissue harmonic imaging Nọte 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 B&W SieScape panoramic imaging
- Note 7
- 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
Mary Stadel
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K111674
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{11}------------------------------------------------
S2000 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 S2000 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 | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, 11 | |||
| Abdominal | ||||||||||
| IntraoperativeAbdominal | ||||||||||
| IntraoperativeNeurological | ||||||||||
| 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 | ||||||||||
| 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-skeletalConventional | P | P | P | P | P | BMDC | Note 2,3,4,5,6,7,8,10, 11, 14,15 | |||
| Musculo-skeletalSuperficial | P | P | P | P | P | BMDC | Note 2,3,4,5,6,7,8,10, 11, 14,15 | |||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K080334, K093812
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
- 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
- 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
Mury Patel
(Division Sign-Off)
Division of Radiologic Office of In Vitro Diagnostic Device Evaluation and Safety
510K K111674
(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)
{12}------------------------------------------------
S2000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
14L5 Multi-D Array Transducer for use with ACUSON S2000 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 | ||||||||||
| IntraoperativeAbdominal | ||||||||||
| IntraoperativeNeurological | ||||||||||
| 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-skeletalConventional | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10,11, 14 | |||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication: P = previously deared by FDA K# 063085, K072786, K081148, K082142, K093812
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
- B&W SieScape panoramic imaging Note 7
- Power SieScape panoramic imaging Note 8
- Clarify VE vascular enhancement technology Note 10
- Advanced Sieclear spatial compounding Note 11
- Note 14 eSie™ Touch elasticity imaging / FTI
- Note 16 Custom Tissue Imaging
Mary S. Patel
(Division Sign-Off)
Divis on of Radiolonical Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K111674
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{13}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
14L5BV Multi-D Array Transducer for use with ACUSON S2000 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 | |||||||||||
| IntraoperativeAbdominal | |||||||||||
| IntraoperativeNeurological | |||||||||||
| 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 | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 081148, K093812
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
-
Tissue Equalization Technology Note 4
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 16 Custom Tissue Imaging
Mary Slatl
(Division Sign-Off)
Division of Radiological Devic e Evaluation and Safety Office of In
510K K111674
(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)
{14}------------------------------------------------
S2000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use: 4P1 Phased Array Transducer for use with ACUSON S2000 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 | 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 | ||
| IntraoperativeAbdominal | ||||||||||
| IntraoperativeNeurological | ||||||||||
| 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-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063803, K072786, K081148, K083812
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
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
Masy Sastl
(Division Sign-Off)
n of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
K111674
510K
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{15}------------------------------------------------
S2000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
6C2 Curved Array Transducer for use with ACUSON S2000
Device Name: 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 | 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 | |||
| IntraoperativeAbdominal | ||||||||||
| IntraoperativeNeurological | ||||||||||
| 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-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K09034, K093812
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
-
B&W SieScape panoramic imaging Note 7
-
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
Mary Stath
(Division Sign-Off)
of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K111674
(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)
{16}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use: 4C1 Curved Array Transducer for use with ACUSON S2000 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 | 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 | ||
| IntraoperativeAbdominal | ||||||||||
| IntraoperativeNeurological | ||||||||||
| 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-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial |
N = new indication; P = proviously deared by FDA K# 063085, K072786, K081148, K082812
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 Nole 5
- 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
- Note 11 Advanced Sieclear spatial compounding
- eSie™ Touch elasticity imaging / FTI Note 14
- Note 16 Custom Tissue Imaging
Mair Sostel
(Division Sign-Off)
of Radiological Device e Evaluation and Salety Office of In
510K K111674
(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)
. . .
{17}------------------------------------------------
S2000 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 S2000 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 | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10,11 | ||
| Abdominal | N | N | N | N | N | N | BMDC | Note2,3,4,5,6,7,8,10, 11, 14, 16 | ||
| IntraoperativeAbdominal | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | N | N | N | N | N | N | BMDC | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | N | N | N | N | N | N | BMDC | |||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | N | N | N | N | N | N | BMDC | |||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K#
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 SleScape 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
Mary Patel
Division Sign-Off
OM on of Radiological Devices Vitro Diagnostic Device Evaluation and Safety Office of In
510K K111674
(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)
{18}------------------------------------------------
S2000 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 S2000 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 | 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 | |||
| IntraoperativeAbdominal | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K082142, K093812
Additional Comments:
-
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 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
Mary Scott
(Division Sign-Off)
on of Radiolonical Devi Office of In Vitro Diagnostic Device Evaluation and Safety
510K K111674
(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)
{19}------------------------------------------------
S2000 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 S2000 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 | 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 | ||
| IntraoperativeAbdominal | ||||||||||
| IntraoperativeNeurological | ||||||||||
| 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-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K083812
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
- Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
Mary Patel
(Division Sign Off)
of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K 1111674
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{20}------------------------------------------------
S2000 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 S2000 Diagnostic imaging or fluid flow analysis of the human body as follows.
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative(Note 9) | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10 | |||
| IntraoperativeNeurological | 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-skeletalConventional | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10,11,14 | |||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K092812
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
- Tissue Equalization Technology Note 4
- Note 5 3-Scape real-time 3D imaging
- Note 6 Cadence contrast agent imaging
- 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
- Note 11 Advanced Sieclear spatial compounding Note 14 eSie™ Touch elasticity imaging / FTI
Note 15 AHP Note 16 Custom Tissue Imaging
Mary Scottl
of Radiological Device Vitro Diagnostic Device Evaluation and Safety Office of In
510K K111674
(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)
{21}------------------------------------------------
S2000 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 S2000 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 | 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 | |||
| IntraoperativeAbdominal | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatnic | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063803, K072786, K081148, K082142, K093812
Additional Comments:
- Note 2 Ensemble tissue harmonic imaging
- SieClear multi-view spatial compounding Note 3
- 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
- Note 10 Clarify VE vascular enhancement technology
- Note 11 Advanced Siectear spatial compounding
- Note 13 STIC
ו,
Mary Patel
(Division Sign-Off)
on of Radinlorical De Office of In Vitro Diagnostic Device Evaluation and Safety
510K K111674
(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)
S2000 510(k) Submission
Page 30 of 56
{22}------------------------------------------------
S2000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
バー - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
1
9EVF4 Curved Array Transducer for use with ACUSON S2000 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 | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10,11, 13 | |||
| Abdominal | ||||||||||
| IntraoperativeAbdominal | ||||||||||
| IntraoperativeNeurological | ||||||||||
| 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-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063803, K072786, K081148, K082142, K090334, K093812
Additional Comments:
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
B&W SieScape panoramic imaging Note 7
Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology Note 11 Advanced Sieclear spatial compounding
Note 13 STIC
Mary S. Patil
(Division Sign-Off)
ion of Radiological Devices Diagnostic Device Evaluation and Safety
510K Killy
(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)
Image /page/22/Picture/22 description: The image shows a black and white drawing of an abstract shape. The shape is roughly square, but the lines are not straight and the corners are not sharp. The shape is also not solid, but rather made up of a series of lines and dots. The overall effect is one of incompleteness and ambiguity.
1 - - - -
{23}------------------------------------------------
S2000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use: V5Ms Multiplane TEE Transducer for use with ACUSON S2000 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 | ||||||||||
| IntraoperativeAbdominal | ||||||||||
| IntraoperativeNeurological | ||||||||||
| 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-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA K# 063803, K072786, K081148, K082142, K093812
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Additional Comments: Tissue Equalization Technology Note 4
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription Use (Part 21CFR 801 Subpart D)
Mary S Postel
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K Y111674
S2000 510(k) Submission
Page 32 of 56
{24}------------------------------------------------
S2000 Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
17L5HDS Linear Array Transducer for use with ACUSON S2000 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 | ||||||||||
| IntraoperativeAbdominal | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Note 1) | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10,11,14 | ||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10,11,14 | ||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10,11,14 | ||
| Musculo-skeletalSuperficial | P | 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 K# 063085, K072786, K082142, K090334 , K093812
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
Note 4 Tissue Equalization Technology
- 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
Mury Sastel
(Division Sign-Off)
of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K111674
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{25}------------------------------------------------
S2000 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 S2000 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 | ||||||||||
| IntraoperativeAbdominal | ||||||||||
| IntraoperativeNeurological | ||||||||||
| 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-skeletalConventional | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10,11,14 | |||
| Musculo-skeletalSuperficial | 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
Additional Comments:
- Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
- Note 2 Ensemble tissue harmonic imaging
- SieClear multi-view spatial compounding Note 3
- Note 4 Tissue Equalization Technology
- 3-Scape real-time 3D imaging Note 5
- 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
Muss S. Patel
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K 111674
(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)
{26}------------------------------------------------
S2000 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 S2000 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 | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10 | ||
| Abdominal | ||||||||||
| IntraoperativeAbdominal | ||||||||||
| IntraoperativeNeurological | ||||||||||
| 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 | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| 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, K092812
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
- B&W SieScape panoramic imaging Note 7 Power SieScape panoramic imaging
Note 8
Note 10 Clarify VE vascular enhancement technology
Mary Scott
[Division Sign-Off]
of Radiological Devices Divis Office of In Vitro Diagnostic Device Evaluation and Safety
510K K111674
(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: 4V1c Phased Array Transducer for use with ACUSON S2000 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 | 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 | |||
| IntraoperativeAbdominal | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10 | |||
| IntraoperativeNeurological | 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 1015 | |||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 1015 | |||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| 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
Additional Comments:
Note 2 Ensemble tissue harmonic imaging
SieClear multi-view spatial compounding Note 3
- Note 4 Tissue Equalization Technology
- Note 5 3-Scape real-time 3D imaging
Note 6 Cadence contrast agent imaging
- B&W SieScape panoramic imaging Note 7
Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
- Note 15 AHP
Mass Slatel
(Division Sign-Off)
Division of Radiological Devices ice Evaluation and Safety Vitro Diagnostic Dev Office of In
510K K111674
(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)
{28}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
6L3 Transducer for use with ACUSON S2000 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 | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10,11 | ||
| Abdominal | ||||||||||
| IntraoperativeAbdominal | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10,11 | ||
| IntraoperativeNeurological | 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 1015 | ||
| 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-skeletalConventional | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10,11 | ||
| Musculo-skeletalSuperficial | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10,11 |
N = new indication; P = previously cleared by FDA K#'s 052410, 051139, 041319, 032114, 022567, 002807, 973767, 063085, K090334, KD93812
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
- B&W SieScape panoramic imaging Note 7
- Power SieScape panoramic imaging Note 8
- Note 10 Clarify VE vascular enhancement technology
- Note 11 Advanced Sieclear spatial compounding
- Note 15 AHP
Mary S. Pastel
(Division Sign-Off)
Division of Radiological Device Office of Ir Diagnostic Device Evaluation and Safety
510K K 111674
(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)
{29}------------------------------------------------
S2000 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 S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | 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 | ||
| IntraoperativeAbdominal | ||||||||||
| IntraoperativeNeurological | ||||||||||
| 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 7 810 | ||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial |
N = new indication; P = previously cleared by FDA K#'s 052410, 051139, 041319, 032114, 022567, 002807, 973767, 063085, K090334, K093812
Additional Comments:
Note 2 Ensemble tissue harmonic imaging
SieClear multi-view spatial compounding Note 3
Note 4 Tissue Equalization Technology
3-Scape real-time 3D imaging Note 5
Note 6 Cadence contrast agent imaging
- B&W SieScape panoramic Imaging Note 7
Note 8 Power SieScape panoramic Imaging Note 10 Clarify VE vascular enhancement technology
Mary S Patel
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation
510K K111674
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{30}------------------------------------------------
S2000 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 S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | HarmonicImaging | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | P | P | P | P | P | P | P* | P | Note 4 | ||
| IntraoperativeAbdominal | |||||||||||
| IntraoperativeNeurological | |||||||||||
| 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
Additional Comments:
*Combinations include: B+M, B+PWD, 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
Tissue Equalization Technology Note 4
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 Sybpart D)
Mary S. Postel
Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K111674
S2000 510(k) Submission
Page 39 of 56
{31}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
AcuNav 8F Ultrasound Catheter for use with ACUSON S2000
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.
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | Mode of OperationPower(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other:HarmonicImaging |
|---|---|---|---|---|---|---|---|---|---|---|
| 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-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (Intra-Cardiac) | P | P | P | P | P | P | P* |
P=Previously cleared by the FDA K992631, K033650, K042593, K071234, K093812
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)
Mary Slated
(Division Sign-Off)
of Radiological Devices Divisio Office of In Vitro Diagnostic Device Evaluation and Safety
S2000 510{k} Submission
Page 40 of 56
{32}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
AcuNav 10F Ultrasound Catheter for use with ACUSON S2000
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 | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other:HarmonicImaging |
| 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-skeletalConventional | ||||||||||
| Musculo-skeietalSuperficial | ||||||||||
| Other (Intra-Cardiac) | P | P | P | P | P | P | P* |
P=Previously cleared by the FDA K992631, K033650, K042593, K071234, , K093812
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
510K
(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)
Mary Stotil
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
S2000 510(k) Submission
Page 41 of 56
§ 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.