VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K121062 |
|---|---|
| Device Name | VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Ge Medical System Israel , Ltd. |
| Product Code | ITX · Radiology |
| Decision Date | Aug 17, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1570 |
| 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 i and Vivid q are mobile ultrasound consoles for echocardiography, vascular, and general imaging. Systems utilize electronic array transducers to acquire ultrasound signals; process data via internal hardware/software; and display images/measurements. Used in clinical settings by physicians/technicians. Includes EchoPilot reporting software; compares patient data/measurements against clinical guidelines; identifies inconsistencies; generates preliminary analysis for examination reports. Output assists clinicians in diagnostic decision-making and examination quality assurance.
Clinical Evidence
No clinical studies required. Substantial equivalence supported by bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal/electrical/electromagnetic/mechanical safety verification. Quality assurance measures included module, integration, and final acceptance testing.
Technological Characteristics
Mobile ultrasound console; electronic array transducers; B, M, PW/CW Doppler, Color/Power Doppler, Harmonic Imaging, Coded Pulse modes. Biocompatible patient contact materials. Software-based image processing and EchoPilot reporting. Connectivity via standard ultrasound interfaces. Sterilization/disinfection per manufacturer instructions.
Indications for Use
Indicated for ultrasound imaging and analysis in Fetal/Obstetrics, Abdominal/GYN, Pediatric, Small Organ, Neonatal/Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal, Urology, Transesophageal, Transrectal, Transvaginal, and Intraoperative applications. Intended for use by or under the direction of a qualified physician.
Regulatory Classification
Identification
A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.
Predicate Devices
- Vivid i and Vivid q Diagnostic Ultrasound Systems (K102388)
- Vivid E9 Diagnostic Ultrasound System (K101149)
Related Devices
- K102393 — VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM; VIVID S6 DIAGNOSTICULTRASOUND SYSTEM · Ge Medical System Israel , Ltd. · Nov 5, 2010
- K121063 — VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM · Ge Medical System Israel , Ltd. · Aug 21, 2012
- K092079 — MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND · Ge Medical Systems Israel, Ultrasound, Ltd. · Aug 6, 2009
- K200851 — Vivid T8, Vivid T9 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Sep 9, 2020
- K200743 — Vivid E80/ Vivid E90/ Vivid E95 · Ge Medical Systems Ultrasound And · Jul 23, 2020
Submission Summary (Full Text)
{0}------------------------------------------------
# k |21062
AUG 1 7 2012
-
## 510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | 5 April 2012 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Healthcare<br>9900 Innovation Dr<br>Wauwatosa, WI 53226 |
| Primary Contact Person: | Bryan Behn<br>Regulatory Affairs Manager<br>GE Healthcare,<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 i and Vivid q Diagnostic Ultrasound System |
| Common/Usual Name: | Vivid i, Vivid q |
| 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<br>Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX<br>Picture Archiving and Communication System, 21 CFR 892.2050, 90-LLZ |
| Predicate Device(s): | Vivid i and Vivid q Diagnostic Ultrasound Systems, K102388.<br>Vivid E9 Diagnostic Ultrasound System, K101149. |
| Device Description: | The Vivid i and Vivid q are mobile ultrasound consoles having a wid 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 auto-optimization along with significantly reduced size and weight make it readily maneuverable, efficient and easy to use. |
| 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) |
{1}------------------------------------------------
The device may include EchoPilot reporting software which provides guidance to support the quality of the echocardiography examination and report. It compares patient data, user entered clinical data and measurements to generally accepted guidelines and studies, and helps to identify mismatches, inconsistencies and unusual or missing data. It can generate a preliminary data analysis that can be used as basis for the examination report.
Technology: The modified Vivid i/q 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 i/q 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 i/q, did not require clinical studies to support substantial equivalence.
Conclusion: GE Healthcare considers the modified Vivid i/q to be as safe, and effective as the predicate device(s). The performance of the modified Vivid i/q 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 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.
{2}------------------------------------------------
Therefore, it is the opinion of GE Healthcare that the Vivid i/q Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
{3}------------------------------------------------
#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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-like figure with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.
#### Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
GE Medical Systems Israel Ltd. % Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 Innovation Drive WAWATOSA WI 53226
AUG 1 7 2012
Re: K121062
Trade/Device Name: Vivid i/q 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
| 3S-RS | 8C-RS |
|--------|---------|
| 3Sc-RS | E8C-RS |
| 5S-RS | 3C-RS |
| 6S-RS | 8L-RS |
| 7S-RS | 9L-RS |
| 10S-RS | 12L-RS |
| 12S-RS | i12L-RS |
| M4S-RS | 6Tc-RS |
| 4C-RS | 6T-RS |
{4}------------------------------------------------
| 9T-RS | AcuNav TM 8F |
|---------------|------------------|
| P2D | SoundStar 3D 10F |
| P6D | SoundStar eco10F |
| AcuNav TM 10F | |
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 Joshua Nipper at (301) 796-6524.
Sincerely Yours,
ichal D'Ohm 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)
{5}------------------------------------------------
#### 510(k) Number (if known): K121062
Device Name: Vivid i/q
Indications for Use:
The Vivid i/q ultrasound systems are intended for use by, or under the direction of, a qualified physician for ultrasound imaging and analysis in 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; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
The device may include EchoPilot reporting software which provides guidance to support the quality of the echocardiography examination and report. It compares patient data, user entered clinical data and measurements to generally accepted guidelines and studies, and helps to identify mismatches, inconsistencies and unusual or missing data. It can generate a preliminary data analysis that can be used as basis for the examination report.
Prescription Use X Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 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)
Mhald. D. Shene
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K121062
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circle. The logo is black and white.
### Diagnostic Ultrasound Indications for Use Form Vivid i and Vivid q 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 | P | P | P | P | P | P | P | P | P | P | | |
| 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)[2] | P | P | P | | P | P | P | P | P | P | | |
| 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 | P | P | P | P | P | P | P | P | P | P | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | | |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | | |
| Other[4] | P | P | P | | P | P | P | P | P | P | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | | P | P | P | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | P | P | P | | P | P | P | P | P | P | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative (specify)[5] | P | P | P | P | P | P | P | P | P | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intracardiac and Intraluminal | P | P | P | P | P | P | | P | P | | | |
| 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 B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD,
or digitally encoded harmonics.
(Division Sign-Off)
Division of Radiological Devices
510
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'G' and 'E' intertwined within a circular frame. The letters are stylized and connected in a flowing, cursive-like manner. The logo is presented in black and white, with the letters and the frame appearing in black against a white background.
April 5, 2012
Vivid i/q Ultrasound System
#### Diagnostic Ultrasound Indications for Use Form
#### GE Vivid i/q 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 | |
| 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 | P |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | |
| 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.
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
Coded Pulse is 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 Diagnostic Devices (OIVD)
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined and enclosed within a circular border. The letters and the border are in black, contrasting with the white background.
### GE Vivid i/q 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 | E | E | E | E | E | E | E | E | E | E | |
| Abdominal [1] | E | E | E | E | E | E | E | E | E | E | |
| Pediatric | E | E | E | E | E | E | E | E | E | E | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | E | E | E | E | E | E | E | E | E | E | |
| Cardiac [2] | E | E | E | E | E | E | E | E | E | E | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | |
| 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.
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
is for digitally encoded harmonics. ded
# #
(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)
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular frame. The letters and the frame are solid black, creating a strong contrast against the white background. There are small white dots around the frame.
### GE Vivid-i/q with 5S-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 | | |
| Abdominal | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | | |
| Small Organ (specify) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[1] | 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 | | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes:
[1] Cardiac is Adult and Pediatric.
[*] Combined modes are B/M, B/Color M, B/PWD, B/CWD, B/Color/PWD, B/Power/PWD.
[1] Coded Pulse is for digitally encoded harmonics.
(Division Sign-Off)
0177
SIOK
of Radiological Devices
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The letters are stylized and connected, and the entire logo is presented in black against a white background.
#### Diagnostic Ultrasound Indications for Use Form
#### GE Vivid i/q 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 | | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | | |
| Pediatric | P | P | P | P | P | P | P | P | P | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[2]<br>- | 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 | | | | P | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes:
[1] Abdominal includes GYN/Pelvic and Renal.
gis Adult and Pediatric.
ed modes are B/M, B/Color M, B/PWD, B/CWD, B/Color/PWD, B/Power/PWD.
s for urgittally encoded harmonics.
Division Signdiological 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)
{11}------------------------------------------------
Image /page/11/Picture/0 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 white and set against a solid black circular background. The logo is surrounded by a white border.
### GE Vivid i/q 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 | P | P | P | P | P | P | P | P | P | | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | | |
| Pediatric | P | P | P | P | P | P | P | P | P | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[2] | P | P | P | P | P | P | P | P | P | | |
| Peripheral Vascular | 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 | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | |
| 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.
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
---
(Division Sign-Off)
Division of Radiological Devices
Elok
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{12}------------------------------------------------
Image /page/12/Picture/0 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, contrasting with the white background.
#### GE Vivid i/q 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 | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | | | |
| Small Organ (specify) | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[2] | P | P | P | P | P | P | P | P | P | | | |
| Peripheral Vascular | 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 | | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | | |
| 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.
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD,
(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 of Radiological Devices
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circle. The letters and the circle are black, and the background is white.
## GE Vivid i/q 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 | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | |
| 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.
*] Gombined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD, B/Power/PWD.
(Division Sign-Off)
Division of Radiological Devices
adiological Devices 10k
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The letters and the frame are in black, while the background is white. The logo has a classic and recognizable design.
#### GE Vivid i/q 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 | CW<br>Doppler 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 | | |
| 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 | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeleta! Superficial | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | | |
| 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.
[4] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD,
[] Coded Pulse is for digitally encoded harmonics.
h DDhm
(Division Sign-Off)
Division of Radiological Devices
2
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
of Radiological Devices
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. There are three decorative swirls around the outside of the circle.
#### GE Vivid i/q with 4C-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 | |
| Abdominal[1] | P | P | P | | P | P | P | P | P | P | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[2] | P | P | P | | P | P | P | P | P | P | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | |…
