MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND
Device Facts
| Record ID | K092079 |
|---|---|
| Device Name | MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND |
| Applicant | Ge Medical Systems Israel, Ultrasound, Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Aug 6, 2009 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal/Obstetrics; Abdominal/GYN; 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; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
Device Story
GE Vivid S5/S6 are mobile ultrasound consoles for echocardiography, vascular, and general imaging. System utilizes electronic array transducers to acquire ultrasound signals; processes data via internal software to generate B-mode, M-mode, PW/CW/Color/Power Doppler, and harmonic imaging outputs. Operated by physicians in clinical settings. Output displayed on console for real-time visualization, measurement, and analysis of anatomy and blood flow. Enhances diagnostic capabilities for various clinical applications; supports clinical decision-making through high-resolution imaging and auto-optimization features.
Clinical Evidence
No clinical data required. Device evaluated via non-clinical bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, and mechanical safety, confirming conformance to applicable standards.
Technological Characteristics
Mobile ultrasound console with electronic array transducers. Supports B, M, PW/CW/Color/Power Doppler, and harmonic imaging. Conforms to 21 CFR 820 and ISO 13485 quality systems. Safety verified against medical device standards for acoustic output, thermal, electrical, and mechanical safety.
Indications for Use
Indicated for ultrasound evaluation of fetal/obstetrics, abdominal/GYN, pediatric, small organ, neonatal/adult cephalic, cardiac, peripheral vascular, musculoskeletal, urology, transesophageal, transvaginal, and intraoperative applications. For use by qualified physicians.
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
- GE Vivid S5 and Vivid S6 Diagnostic Ultrasound System (K071985)
- Vivid 7 BT05 (K051449)
- GE LOGIQ Book Ultrasound (K032477)
- Vivid i/q (K082374)
- Vivid E9 (K081921)
- LOGIQ 9 (K011188)
- LOGIQ P5 (K060993)
Related Devices
- K121063 — VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM · Ge Medical System Israel , Ltd. · Aug 21, 2012
- K102393 — VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM; VIVID S6 DIAGNOSTICULTRASOUND SYSTEM · Ge Medical System Israel , Ltd. · Nov 5, 2010
- K101149 — GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM · Ge Vingmed Ultrasound AS · Oct 13, 2010
- K060542 — GE VIVID 7 MODEL FC008XX, GE VIVID 7 MODEL FC009XX · General Electric Co. · Mar 31, 2006
- K142323 — Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System · Ge Medical Systems Israel , Ltd. · Oct 10, 2014
Submission Summary (Full Text)
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K092079
# Attachment B Summary of Safety and Effectiveness
g
GE Healthcare
General Electric Company 3000 N. Grandview Blvd., Waukesha, WI 53188
| 1. Submitter: | GE Healthcare<br>3000 N. Grandview Blvd., W450<br>Waukesha, WI 53188<br>USA |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James T. Turner, MS, RAC<br>USA Premarket RA Leader<br>Telephone: 262-544-3359; Fax: 414-908-9225 |
| Date Prepared: | June, XX 2009 |
| 2. Device Name: | GE Vivid S5 and Vivid S6 Diagnostic Ultrasound System<br>Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN<br>Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO<br>Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX |
- . 3. Marketed Device: GE Vivid S5 and Vivid S6 Diagnostic Ultrasound System, K071985 currently in commercial distribution.
- Device Description: The GE Vivid S6 are mobile ultrasound consoles having a wide 4. assortment of electronic array transducers intended primarily for echocardiography with additional capability in vascular and general ultrasound imaging. Its intuitive user interface, high level of autooptimization along with significantly reduced size and weight maneuverable, efficient and easy to use.
- Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of 5. Fetal/Obstetrics; Abdominal/GYN; 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; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
- 6. Comparison with Predicate Device: The modified GE Vivid S5/S6 is of a comparable type and substantially equivalent to the current GE Vivid S5/S6. It has the same overall characteristics, key safety and effectiveness features, physical design, construction, and materials, and has the same intended uses and operating modes as the predicate device and additional software that are similar to other cleared GE Ultrasound systems.
- Section b): 7.
- 1. Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been tound to conform with applicable medical device safety standards.
- 2. Clinical Tests: None required.
- 3. Conclusion: 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 GE Vivid S5/S6 Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
### DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
GE Medical Systems Israel, Ultrasound, Ltd. % Mr. James T. Turner USA Premarket RA Leader GE Healthcare, QARA Regions - Americas 3000 N. Grandview Blvd., W450 WAUKESHA WI 53188
AUG 0 6 2009
Re: K092079
Trade/Device Name: GE Vivid S5 and Vivid S6 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: TYN, IYO, and ITX Dated: July 7, 2009 Received: July 9, 2009
Dear Mr. Turner:
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 GE Vivid S5/S6 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| 4C-RS |
|--------|
| 8C-RS |
| E8C-RS |
| 8L-RS |
| 12L-RS |
| 7S-RS |
| 10S-RS |
|---------|
| M4S-RS |
| 6Tc-RS |
| i12L-RS |
| 6S-RS |
| 9L-RS |
{2}------------------------------------------------
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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Robert Ochs at (301) 796-6661.
Sincerely yours,
Heike Lemmer
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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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:
| Clinical<br>Application<br>Anatomy/Region of Interest | Mode of Operation | | | | | | | | | | |
|-------------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|-----------------|-------|
| | 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 | P |
| Musculo-skeletal Superficial | P | 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 | P |
| Transrectal | P | P | P | P | P | P | P | P | P | P | |
| Transvaginal | P | P | P | P | P | P | P | P | P | P | |
| Transurethral | | | | | | | | | | | |
| Intraoperative (specify)[5] | P | P | P | P | P | P | P | P | P | P | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
N = new indication; P = prevlously cleared by FDA on Vivid S5/S6 (K071985); E = added under Appendix E
[1] Abdominal includes GYN/Pelvic and Renal. Notes:
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology.
[5] Intraoperative includes abdominal, thoracic, and vascular (PV).
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Color M.
[↑] Coded Pulse is for digitally encoded harmonics.
(PLEASE DO NOT WAITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription User (Per 21 CFR 801.109)
Heleen
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device
510(k) Number
{4}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form GE Vivid S5/S6 with 4C-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical<br>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 | N | P | P | P | P | | |
| Abdominal[1] | P | P | P | | P | N | P | P | P | P | | |
| Pediatric | P | P | P | | P | N | P | P | P | P | | |
| Small Organ (specify) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Peripheral Vascular | N | N | N | | N | N | N | N | N | N | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other[4] | P | P | P | | P | N | P | P | P | P | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Lanarosconic | | | | | | | | | | | | |
N = new indication - Peripheral Vascular application previously cleared on Vivid 7 BT05 (K051449);
P = previously cleared by FDA on Vivid S5/S6 (K071985); E = added under Appendix E
Notes: [1] Abdominal includes GYN/Pelvic and Renal.
[4] Other use includes Urology.
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Color M.
[+] 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 Device Evaluation (ODE)
Prescription User (Per 21 CFR 801.109)
(Division Sign Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K092079 F-3
{5}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form
### GE Vivid S5/S6 with 8C-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|-------------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|-------|
| Clinical<br>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 | N | P | P | P | P | |
| Pediatric | P | P | P | | P | N | P | P | P | P | |
| Small Organ (specify)[2] | P | P | P | | P | N | P | P | P | P | |
| Neonatal Cephalic | P | P | P | | P | N | P | P | P | P | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | N | N | N | | N | N | N | N | N | N | |
| Peripheral Vascular | P | P | P | | P | N | P | P | P | P | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| | | | | | | | | | | | |
N = new indication - cardiac indication previously cleared on GE LOGIQ Book Ultrasound (K032477);
P = previously cleared by FDA on Vivid S5/S6 (K071985); 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.
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Color M.
[+] 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 Device Evaluation (ODE)
Prescription User (Per 21 CFR 807.109)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K092079
F-4
{6}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form
# GE Vivid S5/S6 with E8C-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|-------------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|-----------------|-------|--|
| Clinical<br>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 | N | P | P | P | P | | |
| Abdominal[1] | P | P | P | | P | N | P | P | P | P | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other[4] | P | P | P | | P | N | P | P | P | P | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | P | P | P | | P | | P | P | P | P | | |
| Transvaginal | P | P | P | | P | N | P | P | P | P | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA on Vivid S5/S6 (K071985); E = added under Appendix E
[1] Abdominal Includes GYN/Pelvic and Renal. Notes:
[4] Other use includes Urology.
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Color M.
[+] 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 Device Evaluation (ODE)
Prescription User (Per21 CFR 801.109)
(Division Sigu-Off)
Division of Reproductive, Abdominal,
and Radiological Device
510(k) Number.
E-S
{7}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form
### GE Vivid S5/S6 with 8L-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|-------------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|-------|
| Clinical<br>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 | N | P | P | P | P | |
| Pediatric | P | P | P | P | P | N | P | P | P | P | |
| Small Organ (specify)[2] | P | P | P | P | P | N | P | P | P | P | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | N | P | P | P | P | |
| Musculo-skeletal Conventional | P | P | P | P | P | N | P | P | P | P | |
| Musculo-skeletal Superficial | P | P | P | P | P | N | P | P | P | P | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA on Vivid S5/S6 (K071985); E = added under Appendix E
[1] Abdominal Includes GYN/Pelvic and Renal. Notes:
[2] Small organ includes breast, testes, thyroid.
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Color M.
[↑] 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 Device Evaluation (ODE)
Prescription User (Per 21 CFR 801.109)
Hul Reen
(Division Sign Off) (Division Sign of Reproductive, Abdominal, and Radiological Devices
{8}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form
### GE Vivid S5/6 with 12L-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|-------------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|-------|--|
| Clinical<br>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 | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | N | P | P | P | P | | |
| Small Organ[2] | P | P | P | | P | N | P | P | P | P | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | N | P | P | P | P | | |
| Musculo-skeletal Conventional | P | P | P | | P | N | P | P | P | P | | |
| Musculo-skeletal Superficial | P | P | P | | P | N | P | P | P | P | | |
| Other (specify) | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intraoperative[5] (specify) | P | P | P | | P | N | P | P | P | P | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA on Vivid S5/S6 (K071985); E = added under Appendix E
Notes:
[2] Small organ includes breast, testes, thyroid.
[5] Intraoperative includes abdominal, thoracic), and vascular (PV).
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Color M.
{↓] 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 Device Evaluation (ODE) Prescription User (Per 21 CFR 801:109)
Nul Reen
(Division Sign-Off) Division of Reproductive, Abdominal, und Radiological Devices
510(k) Number
{9}------------------------------------------------
# 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<br>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 [3] | P | P | P | P | P | P | P | P | P | P | | |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other [4] | P | P | P | P | P | P | P | P | P | P | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication - previously cleared by FDA on Vivid i/q (K082374);
P = previously cleared by FDA on Vivid S5/S6 (K071985); E = added under Appendix E
[1] Abdominal includes GYN/Pelvic and Renal. Notes:
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology.
[*] Combined modes are B/M, B/PWD, B/Cotor/PWD, B/Power/PWD, B/Color M.
[+] 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 Davice Evaluation (ODE)
Prescription User (Per 21 OFR 801.109)
Neel Keem
(Division Sign-Off) (Division Sigh-Uff)
Division of Reproductive, Abdominal, Division of the first
510(k) Number.
{10}------------------------------------------------
# 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<br>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[3] | P | P | P | P | P | P | P | P | P | P | | |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication -previously cleared by FDA on Vivid I/q (K082374);
P = previously cleared by FDA on Vivid S5/S6 (K071985); E = added under Appendix E
Notes: [1] Abdominal includes GYN/Pelvic and Renal.
[3] Cardiac is Adult and Pediatric.
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Color M.
[+] 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 Device Evaluation (ODE)
Prescription User (Per 21 CFR 801.109)
Description User (For P-21 or P-21T/P-21TS)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devi
Radiological Devices
510(k) Number K092079
{11}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
# GE Vivid S5/S6 with M4S-RS Transducer
Intended Use: Ultrasound imaging, measurement and 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 | N | N | N | N | N | N | N | N | N | N | | |
| Abdominal[1] | N | N | N | N | N | N | N | N | N | N | | |
| Pediatric | N | N | N | N | N | N | N | N | N | N | | |
| Small Organ (specify) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | N | | |
| Cardiac[3] | N | N | N | N | N | N | N | N | N | N | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication, (Transducer previously cleared on Vivid 7 BT05 (K051449)); P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN/Pelvic and Renal.
[3] Cardiac is Adult and Pediatric.
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Color M.
[+] 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 Device Evaluation (ODE)
Prescription User (Per 21 CFR 801.109)
Herbeem
(Division Sign-Off) (Division Sign-On)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number.
{12}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
# GE Vivid S5/S6 with 6Tc-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 Modes | Harmonic<br>Imaging | Coded<br>Pulse* | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac <sup>[3]</sup> | N | N | N | N | N | N | N | N | N | N | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | N | N | N | N | N | N | N | N | N | N | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication (Transducer previously cleared on Vivid Vq K082374); P = previously cleared by FDA;
E = added under Appendix E
Notes:
[3] Cardiac is Adult and Pediatric.
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Color M.
[♦] 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 Device Evaluation (ODE)
Prescription User (Per 21 CFR 801.109)
Signature
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number
{13}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form
# GE Vivid S5/S6 with i12L-RS Transducer
Intended Use: Ultrasound imaging, measurement and 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 | N | |
| Pediatric | N | N | N | N | N | N | N | N | N | N | |
| Small Organ (specify)[2] | N | N | N | N | N | N | N | N | N | N | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | N | N | N | N | N | N | N | N | N | N | |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | |
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | N | N | |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | N | N | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify)[5] | N | N | N | N | N | N | N | N | N | N | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | |…
