VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K121063 |
|---|---|
| Device Name | VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Ge Medical System Israel , Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Aug 21, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal/Gynecology; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
Device Story
Vivid S5/S6 are mobile ultrasound consoles for echocardiography, vascular, and general imaging. System uses electronic array transducers to acquire ultrasound signals; processes data to produce real-time diagnostic images and flow analysis. Operated by physicians or qualified clinicians in clinical settings. Provides B-mode, M-mode, PW/CW/Color/Power Doppler, and harmonic imaging. Output displayed on console for real-time visualization and clinical assessment. Auto-optimization features assist image quality. System aids in diagnosis and clinical decision-making across various anatomical regions. Benefits include portability, maneuverability, and efficient workflow for diagnostic examinations.
Clinical Evidence
Bench testing only. No clinical studies were required to support substantial equivalence. Device performance was verified through risk analysis, design reviews, module/system-level verification, and final validation testing. Compliance with safety standards for acoustic output, biocompatibility, and electrical/mechanical safety was confirmed.
Technological Characteristics
Mobile ultrasound console with electronic array transducers. Supports B, M, PW/CW/Color/Power Doppler, and harmonic imaging modes. Connectivity via -RS series connectors. Biocompatible patient-contact materials. Conforms to 21 CFR 820 and ISO 13485 quality systems. Safety verified per applicable medical device standards.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis in fetal/obstetrics, abdominal/GYN, pediatric, small organ, neonatal/adult cephalic, cardiac, peripheral vascular, musculoskeletal, urology, transesophageal, transrectal, transvaginal, and intraoperative applications. For use by or under the direction of a qualified physician.
Regulatory Classification
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.
Predicate Devices
- Vivid S5 and Vivid S6 Diagnostic Ultrasound Systems (K102393)
- Vivid E9 Diagnostic Ultrasound System (K101149)
Reference Devices
- 10S-RS (K071985, K092079)
- 7S-RS (K071985, K092079)
- Vivid i/q (K082374)
- 12S-D (K101149)
- 12L-RS (K113690)
Related Devices
- K092079 — MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND · Ge Medical Systems Israel, Ultrasound, Ltd. · Aug 6, 2009
- K102393 — VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM; VIVID S6 DIAGNOSTICULTRASOUND SYSTEM · Ge Medical System Israel , Ltd. · Nov 5, 2010
- K170878 — Vivid S60N, Vivid S70N · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Jun 14, 2017
- K142323 — Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System · Ge Medical Systems Israel , Ltd. · Oct 10, 2014
- K101149 — GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM · Ge Vingmed Ultrasound AS · Oct 13, 2010
Submission Summary (Full Text)
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K121063
# GE Healthcare
510(k) Premarket Notification Submission
Vivid S5/S6 Ultrasound System
#### 510(k) Summary
| | In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|--|------------------------------------------------------------------------------------|--|
| | | |
| Date: | 5 April 2012 | | | | | AUG 2 1 2012 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--------------|
| Submitter: | GE Healthcare<br>9900 Innovation Dr<br>Wauwatosa, WI 53226 | | | | | |
| Primary Contact Person: | Bryan Behn<br>Regulatory Affairs Manager<br>GE Healthcare, [GE Medical Systems Ultrasound and Primary Care<br>Diagnostics, LLC]<br>T:(414)721-4214<br>F:(414)918-8275 | | | | | |
| Secondary Contact Person: | Carmel Lehrer<br>Regulatory Affairs Specialist<br>GE Medical Systems Israel Ltd.<br>T:+972-4-8419-534<br>F:+972-4-8419-500 | | | | | |
| Device: Trade Name: | Vivid S5 and Vivid S6 Diagnostic Ultrasound System | | | | | |
| Common/Usual Name: | Vivid S5, Vivid S6 | | | | | |
| Classification Names: | Class II | | | | | |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN<br>Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO | | | | | |
| Predicate Device(s): | Vivid S5 and Vivid S6 Diagnostic Ultrasound Systems, K102393.<br>Vivid E9 Diagnostic Ultrasound System, K101149. | | | | | |
| Device Description: | The Vivid S5 and Vivid S6 are mobile ultrasound consoles having a<br>wide assortment of electronic array transducers intended primarily for<br>echocardiography with additional capability in vascular and general<br>ultrasound imaging. Its intuitive user interface, high level of auto-<br>optimization along with significantly reduced size and weight make<br>it readily maneuverable, efficient and easy to use. | | | | | |
| Intended Use: | The device is intended for use by a qualified physician for ultrasound<br>evaluation of Fetal/Obstetrics; Abdominal/Gynecology; Pediatric;<br>Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult<br>Cephalic; Cardiac (adult and pediatric); Peripheral Vascular;<br>Musculo-skeletal Conventional and Superficial; Urology (including<br>prostate); Transesophageal; Transrectal; Transvaginal; and | | | | | |
・
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Image /page/1/Picture/1 description: The image shows a circular logo with the letters 'GE' intertwined in the center. The letters are stylized with curved lines and loops, creating a flowing and interconnected design. The logo is enclosed within a circle that has a textured or patterned border, adding a decorative element to the overall design. The image is in black and white.
Technology: The modified Vivid S5/S6 employs the same fundamental scientific technology as its predicate devices.
Determination of Substantial Equivalence:
#### Summary of Non-Clinical Tests:
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 modified Vivid S5/S6 and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- Risk Analysis ●
- Requirements Reviews .
- Design Reviews .
- Testing on unit level (Module verification) .
- . Integration testing (System verification)
- Final Acceptance Testing (Validation) .
- . Performance testing (Verification)
- Safety testing (Verification) .
Transducer materials and other patient contact materials are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission, the modified Vivid S5/S6, did not require clinical studies to support substantial equivalence.
GE Healthcare considers the modified Vivid S5/S6 to be as safe, and effective as the predicate device(s). The performance of the modified Vivid S5/S6 is substantially equivalent to the predicate device(s).
Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820, and ISO13485 quality systems. The device conforms to 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 GE Healthcare that the Vivid S5/S6 Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
Conclusion:
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.
#### Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
AUG 2 1 2012
GE Medical Systems Israel Ltd. % Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 Innovation Drive WAUWATOSA WI 53226
Re: K121063
Trade/Device Name: Vivid S5/S6 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, and LLZ Dated: August 10, 2012 Received: August 13, 2012
#### Dear Mr. Behn:
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 Vivid S5/S6, as described in your premarket notification:
#### Transducer Model Number
| 38-RS | 108-RS | E8C-RS | 6Tc/6Tc-RS |
|---------|--------|---------|------------|
| 3Sc-RS | 12S-RS | 8L-RS | 6T/6T-RS |
| 58-RS | M4S-RS | 9L-RS | 9T/9T-RS |
| 68-RS . | 4C-RS | 12L-RS | P2D |
| 78-RS | 8C-RS | i12L-RS | P6D |
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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 Jeffrey Ballyns at (301) 796-6105.
Sincerely Yours,
Marlon Dóthan 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
Enclosure(s)
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Image /page/4/Picture/1 description: The image shows a black and white logo. The logo is circular and contains the letters 'GE' intertwined in the center. The letters are stylized and appear to be handwritten. The background of the circle is black, and the letters are white.
510(k) Number (if known):
Device Name: Vivid S5/S6
Indications for Use:
The current modifications do not change the indications for use. As previously reported and cleared, the Vivid S5/S6 ultrasound systems are intended for use by, or under the direction of, a qualified the Vira 65/00 and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small physiolan for untrasound maging and Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Organ (vertes), Musculo-skeletal Conventional and Superficial; Urology (including prostate); I cripiteral Vascular, Museulo Skelear Senal; and Intraoperative (abdominal, thoracic, and vascular).
Prescription Use_ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
A. Shard D. O'Hern
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K121063
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Image /page/5/Picture/0 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border that has a decorative, swirling pattern around the edges.
#### Indications for Use Forms
The following forms represent indications with clinical applications and exam types along with the modes of operation for the Vivid S5/S6 system and for all of its probe/mode combinations. Combinations identified by "P" represent those previously FDA cleared. In a similar manner "N" represents a new mode or application being added as new to the system or a transducer in this submission. In a similar manner, "E" represents combinations added to the unmodified device via Guidance Appendix E. This modification did not alter the previously cleared system level indications, clinical applications or modes of operation.
Indications for Use tables' headings, legends and footers taken from all previous submissions, are aligned to the same unified format.
#### Pencil probes
PW mode of operation, which was previously included in error for the Pencil probes; P2D and P6D, has been removed from their Indications for Use forms.
#### 128-RS
The 12S-RS is identical to the 12S-D previously cleared on the Vivid E9 K101149 with a change to the -RS laptop/small console connector instead of the -D large console connector. Clinical applications and modes of operation are as in 12S-D. Additional Abdominal Vascular applications are added to 12S-RS based on clearance of these applications on other transducers (10S-RS and 7S-RS) previously cleared on Vivid S5/S6 (K071985, K092079) and Vivid i/q (K082374).
#### Transducers added via Appendix E: 3Sc-RS
One transducer has been added via Appendix E of the Ultrasound Guidance since the previous clearance. Transducer 3Sc-RS, which is similar to the previously cleared 3S-RS with a few minor improvements.
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# Diagnostic Ultrasound Indications for Use Form GE Vivid S5/S6 Diagnostic Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|-----------------|-------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse* | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal/Obstetrics | P | P | P | P | P | P | P | P | P | P | P |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | P |
| Pediatric | P | P | P | P | P | P | P | P | P | P | P |
| Small Organ (specify)[2] | P | P | P | P | P | P | P | P | P | P | P |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | P |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | P |
| Cardiac [3] | P | P | P | P | P | P | P | P | P | P | P |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | P |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | P | |
| Other[4] | P | P | P | P | P | P | P | P | P | P | P |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | P | |
| Transrectal | P | P | P | P | P | P | P | P | P | P | |
| Transvaginal | P | P | P | P | P | P | P | P | P | P | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify)[5] | P | P | P | P | P | P | P | P | P | P | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes:
- [1] Abdominal includes GYN/Pelvic and Renal.
- [2] Small organ includes breast, testes, thyroid.
- [3] Cardiac is Adult and Pediatric.
- [4] Other use includes Urology.
- [5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
- [*] Combined modes are BIM, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD,
રીભ
- [�] Coded Pulse is for digitally encoded harmonics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Slan of Radiological
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription Use (Per 21 CFR 801.109)
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Image /page/7/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are in black, and the background is white.
Diagnostic Ultrasound Indications for Use Form
## GE Vivid S5/S6 with 3S-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|-----------------|-------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse* | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal/Obstetrics | P | P | P | P | P | P | P | P | P | P | P |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | P |
| Pediatric | P | P | P | P | P | P | P | P | P | P | P |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | P |
| Cardiac[2] | P | P | P | P | P | P | P | P | P | P | P |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[3] | P | P | P | P | P | P | P | P | P | P | P |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes:
[1] Abdominal includes GYN/Pelvic and Renal.
[2] Cardiac is Adult and Pediatric.
[3] Other use includes Urology.
[0] Other use Includes Grology:
[*] Combined modes are BIM, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD,
[♦] Coded Pulse is for digitally encoded harmonics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) | |
|-------------------------------------------------------------------|----------------------------------|
| (Division Sign-Off) | |
| Prescription Use (Per 21 CFR 801.109) | Division of Radiological Devices |
| 510k | K191063 |
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Image /page/8/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is in black and white.
510(k) Premarket Notification Submission Vivid S5/S6 Ultrasound System April 5, 2012
# Diagnostic Ultrasound Indications for Use Form GE Vivid S5/S6 with 3Sc-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|-----------------|-------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse® | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal/Obstetrics | m | E | E | E | E | E | E | E | E | 트 | |
| Abdominal[1] | E | E | E | E | E | E | E | E | E | .U | |
| Pediatric | E | E | 트 | E | E | E | E | E | E | E | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | E | E | E | E | E | ന | 는 | E | E | E | |
| Cardiac(2) | E | E | E | E | E | E | E | E | E | E | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Olbergi | ビ | E | E | E | E | E | E | E | ട് | E | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes:
[1] Abdominal includes GYN/Pelvic and Renal.
[2] Cardiac is Adult and Pediatric.
[3] Other use includes Urology.
[0] Other use included Grology.
[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Color/PWD, B/Power/PWD.
[+] Coded Pulse is for digitally encoded harmonics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) | |
|------------------------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Prescription Use (Per 21 CFR 801,109) Division of Radiological Devices | |
| 510k | K121063 |
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Image /page/9/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border. The logo is black and white.
510(k) Premarket Notification Submission April 5, 2012 Vivid S5/S6 Ultrasound System
### Diagnostic Ultrasound Indications for Use Form
## GE Vivid S5/S6 with 5S-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse* | Other |
|----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|-----------------|-------|
| Ophthalmic | | | | | | | | | | | |
| Fetal/Obstetrics | P | P | P | P | P | P | P | P | P | P | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | |
| Cardiac[2] | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
#### Notes:
[1] Abdominal includes GYN/Pelvic and Renal.
[2] Cardiac is Adult and Pediatric.
[2] Cordiao is Addit and 7 Collutio:
[*] Combined modes are BIM, B/Color M, B/PWD, B/CWD, B/Color/PWD, B/Power/PWD.
[♦] Coded Pulse is for digitally encoded harmonics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH/ Office of In Vitro Diagnostic Devices (OIVD) | |
|-------------------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Prescription Use (Per 21 CFR 801.109) | |
| Division of Radiological Devices | |
| 510k | K121063 |
| OIVD | |
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Image /page/10/Picture/1 description: The image shows a logo of General Electric (GE). The logo is a circular design with the letters "GE" intertwined in the center. The letters are stylized and have a swirling, cursive appearance. The logo is black and white, with the letters and the outer circle being black and the background being white.
510(k) Premarket Notification Submission Vivid S5/S6 Ultrasound System April 5, 2012
# Diagnostic Ultrasound Indications for Use Form GE Vivid S5/S6 with 6S-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|-----------------|-------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse* | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal/Obstetrics | P | P | P | P | P | P | P | P | P | P | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[2] | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
#### Notes:
[1] Abdominal includes GYN/Pelvic and Renal.
[2] Cardiac is Adult and Pediatric.
[2] Combined modes are BIM, B/PWD, B/CWD, B/Color/PWD, B/Color/PWD, B/Power/PWD.
[♦] Coded Pulse is for digitally encoded harmonics.
(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 (Per 21 CFR 801.109) | |
| (Division Sign-Off) | |
| Division of Radiological Devices | |
| 510k | DIVD |
{11}------------------------------------------------
Image /page/11/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The design is simple and recognizable, representing the company's brand identity.
510(k) Premarket Notification Submission April 5, 2012 Vivid S5/S6 Ultrasound System
## Diagnostic Ultrasound Indications for Use Form
### GE Vivid S5/S6 with 7S-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|-----------------|-------|--|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse* | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal/Obstetrics | | | | | | | | | | | | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | | |
| Small Organ (specify) | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[2] | P | P | P | P | P | P | P | P | P | P | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other[3] | P | P | P | P | P | P | P | P | P | P | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes:
[1] Abdominal includes GYN/Pelvic and Renal.
[2] Cardiac is Adult and Pediatric.
[3] Other use includes Urology.
[0] Other boo included Crelogy.
[*] Combined modes are BIM, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[�] Coded Pulse is for digitally encoded harmonics.
(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 (Per 21 CFR 801.109) | |
| (Division Sign-Off) Division of Radiological Devices | |
| 510k | |
{12}------------------------------------------------
Image /page/12/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The letters are stylized and appear to be in a cursive or script font. The logo is black and white.
510(k) Premarket Notification Submission Vivid S5/S6 Ultrasound System April 5, 2012
# Diagnostic Ultrasound Indications for Use Form
## GE Vivid S5/S6 with 10S-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|-----------------|-------|--|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse* | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal/Obstetrics | | | | | | | | | | | | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | | |
| Small Organ (specify) | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | | |
| Cardiac[2] | P | P | P | P | P | P | P | P | P | P | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes:
- [1] Abdominal includes GYN/Pelvic and Renal.
[2] Cardiac is Adult and Pediatric.
- [2] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD,
- Leoded Bolse is for digitally encoded harmonics.
(Division Sign-Off) Division of Radfording Real Devices Division of puplicilogical Devices 510k
210k
(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 (Per 21 CFR 801.109)
{13}------------------------------------------------
Image /page/13/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized with curved lines, and the border has a textured appearance.
## Diagnostic Ultrasound Indications for Use Form GE Vivid S5/S6 with 12S-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|-------|--|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal/Obstetrics | | | | | | | | | | | | |
| Abdominal[1] | N | N | N | N | N | N | N | N | N | | | |
| Pediatric | N | N | N | N | N | N | N | N | N | | | |
| Small Organ (specify) | | | | | | | | | | | | |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[2] | N | N | N | N | N | N | N | N | N | | | |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes:
[1] Abdominal includes GYN/Pelvic and Renal.
[2] Cardiac is Adult and Pediatric.
[2] Combined modes are BIM, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD,
(Division Sign-off)
Division of Radiological Devices
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 (Per 21 CFR 801.109)
{14}------------------------------------------------
Image /page/14/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized and appear to be hand-drawn or calligraphic. The logo is black and white.
510(k) Premarket Notification Submission April 5, 2012 Vivid S5/S6 Ultrasound System
# Diagnostic Ultrasound Indications for Use Form GE Vivid S5/S6 with M4S-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|-----------------|-------|--|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse* | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal/Obstetrics | P | P | P | P | P | P | P | P | P | P | | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | | |
| Pediatric | P | P | P | P | P | P | P | P | P | | | |
| Small Organ (specify) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | | |
| Cardiac[2] | P | P | P | P | P | P | P | P | P | P | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes:
[1] Abdominal includes GYN/Pelvic and Renal.
[2] Cardiac is Adult and Pediatric.
(2) Carthat is Adult and Pediatio
[*] Combined modes are B/M, B/Color M, B/PWD, B/CWD, B/Color/PWD, B/Power/PWD.
(+] Coded Pulse for digitally encoded harmonics.
(Division Sign-Off)
Division of Radiological Devices
510K
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Dlagnostic Devices (OIVD)
{15}------------------------------------------------
Image /page/15/Picture/1 description: The image shows a logo with the letters 'GE' intertwined within a circle. The letters are stylized and appear to be hand-drawn or calligraphic. The logo is black and white, with the letters and the outline of the circle in black against a white background. The logo is a vintage design, likely representing the General Electric company.
510(k) Premarket Notification Submission Vivid S5/S6 Ultra…
