GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
Device Facts
| Record ID | K102104 |
|---|---|
| Device Name | GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM |
| Applicant | Wipro GE Healthcare Private, Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Oct 1, 2010 |
| Decision | SESE |
| Submission Type | Special |
| 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 Cardiac (adult and pediatric), Peripheral Vascular. Fetal/Obstetrics. Abdominal (including GYN), Pediatric, Small Organ (including breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Intra operative (abdominal, thoracic and peripheral), Musculo-skeletal Conventional, Urology (including prostate). Transrectal and Transvaginal.
Device Story
Vivid P3 is a mobile, high-performance Color Doppler ultrasound imaging system. It processes acoustic signals from interchangeable electronic-array transducers to generate real-time diagnostic images and fluid flow analysis. Used in clinical settings (cardiovascular, abdominal, neonatal/pediatric, intra-operative) by physicians. The system features a keyboard control panel and LCD display. Clinicians interpret visual ultrasound data to inform diagnostic and therapeutic decisions. Benefits include non-invasive visualization of internal anatomy and blood flow, aiding in the assessment of various disease states.
Clinical Evidence
No clinical data required; substantial equivalence supported by bench testing and verification/validation activities.
Technological Characteristics
Mobile Color Doppler ultrasound system; uses interchangeable electronic-array transducers. Supports B, M, PW/CW Doppler, Color/Power Doppler, Harmonic Imaging, and 3D modes. Complies with electrical, thermal, and electromagnetic safety standards. Software-based image processing.
Indications for Use
Indicated for ultrasound evaluation of cardiac (adult/pediatric), peripheral vascular, fetal/obstetrics, abdominal (including GYN), pediatric, small organ (breast, testes, thyroid), neonatal/adult cephalic, intraoperative (abdominal, thoracic, peripheral), musculoskeletal, and urological (prostate) applications. For use by qualified physicians. Prescription use only.
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 Logiq e/i & Vivid e (K072797)
- GE Logiq P5/A5 (K060993)
- GE Logiq P6 (K073297)
- GE Vivid S5/S6 (K092079)
Related Devices
- K093488 — ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM · Aloka Co., Ltd. · Nov 20, 2009
- K112371 — LOGIQ P3 · GE Healthcare · Sep 27, 2011
- K101878 — GE LOGIQ P5 MODEL H44662LD · GE Healthcare · Aug 31, 2010
- K020789 — GE VIVID 3 EXPERT; GE VIVID 3 PRO · General Electric Co. · Apr 4, 2002
- K233697 — SonoMax Series Digital Color Doppler Ultrasound System · CHISON Medical Technologies Co., Ltd. · Aug 9, 2024
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/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 enclosed within a circular border, and there are small, decorative flourishes or swirls around the letters within the circle.
# OCT 1 2010
GE Healthcare 510(k) Premarket Notification Submission
K102104
Section 5: 510(k) Summary
VIVID P3
.『
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo, which 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 presented in black against a white background, giving it a high contrast and making it easily recognizable.
OCT 1 2010
K102104
GE Healthcare 510(k) Premarket Notification Submission
# 510(k) Summary
:
| Date: | 16-July-2010 |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | WIPRO GE HEALTHCARE PRIVATE LTD.<br>No. 4, Kadugodi Industrial Area<br>Bangalore, Karnataka - 560067. India. |
| Primary Contact Person: | Bryan Behn<br>Regulatory Affairs Manager<br>GE Healthcare<br>9900 Innovation Dr.<br>Wauwatosa, WI 53226<br>Telephone: 414-721-4214<br>Fax: 414-918-8275 |
| Secondary Contact Person: | Gurunathan M<br>Regulatory Affairs Leader- Product<br>Wipro GE Healthcare Private Ltd<br>Telephone: 91-80-4088-2108<br>Fax: 91-80-2841-1645 |
| Device: | VIVID P3 |
| Classification Names:<br>Product Code: | Diagnostic Ultrasound Imaging System<br>Ultrasonic Pulsed Doppler Imaging System<br>Ultrasonic Pulsed Echo Imaging System and Diagnostic<br>Ultrasonic Transducer |
| | Primary - IYN - 21CFR 892.1550; IYO - 21CFR 892.1560 &<br>Secondary - ITX – 21CFR 892.1570 |
| Predicate Device(s): | GE Logiq e/i & Vivid e - K072797, GE Logiq P5/A5 K060993,<br>GE Logiq P6 K073297, GE Vivid S5/S6 K092079 |
| Device Description: | The VividTM P3 is a high performance, mobile Color Doppler<br>Ultrasound Imaging system. This system is designed for<br>cardiovascular applications and including abdominal<br>neonatal/pediatrics & intra-operative. It is integrated with<br>keyboard control panel, LCD type video display and<br>interchangeable electronic-array transducers. |
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular frame. The letters and the frame are in black, creating a high-contrast design. The logo is simple, recognizable, and represents the General Electric company.
# GE Healthcare 510(k) Premarket Notification Submission
- The device is intended for use by a qualified physician for Intended Use: ultrasound evaluation of Cardiac (adult and pediatric), Peripheral Vascular. Fetal/Obstetrics. Abdominal (including GYN), Pediatric, Small Organ (including breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Intra operative (abdominal, thoracic and peripheral), Musculo-skeletal Conventional, Urology (including prostate). Transrectal and Transvaginal.
- The VIVID P3 employs the same fundamental scientific Technology: technology as its predicate devices.
Determination of Summary of Non-Clinical Tests:
Substantial Equivalence: The device has been evaluated for acoustic output. biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The VIVID P3 and its applications comply with voluntary standards as detailed in Section 9, 11, 15 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- . Risk Management
- Requirement Reviews .
- . Design reviews
- Unit level testing (Module Verification) .
- Integration Testing (System level verification) .
- . Final acceptance testing (Validation)
- Performance testing (Verification) .
- Safety testing (Verification) .
#### Summary of Clinical Tests:
The subject of this premarket submission, VIVID P3, did not require clinical studies to support substantial equivalence.
- GE Healthcare considers the VIVID P3 to be as safe, as effective, Conclusion: and performance is substantially equivalent to the predicate device(s).
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
WIPRO GE Healthcare Private, Ltd. % Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 W Innovation Dr., RP-2138 WAUWATOSA WI 53226
DCT ] 2010
Re: K102104
Trade/Device Name: VIVID P3 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: September 3, 2010 Received: September 8, 2010
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 P3 Ultrasound System, as described in your premarket notification:
Transducer Model Number
4C
E8Cs
8L
8C
5Cs
3S
{4}------------------------------------------------
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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.
Sincerely yours,
Marl O'Keefer for
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters are stylized and connected, creating a unique and recognizable design. The logo is in black and white.
GE Healthcare 510(k) Premarket Notification Submission
510(k) Number (if known):
Device Name: VIVID P3
Indications for Use:
The device is intended for use by a qualified physician for ultrasound evaluation of Cardiac (adult and pediatric), Peripheral Vascular, Fetal/Obstetrics, Abdominal (including GYN), Pediatric, Small Organ (including breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Intra operative (abdominal, thoracic and peripheral), Musculoskeletal Conventional, Urology (including prostate), Transrectal and Transvaginal.
Prescription Use: Yes AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use: No (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)
ikel D. Othen for David G. Brown
(Division Sign-Off)
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
**510(k) Number** K102104
Page 1 of 1
{6}------------------------------------------------
#### GE VIVID P3 Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|-------------------------------|-------------------|---|---------|---------|---------|---------|---------|----------|----------|-------|---------|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | Combined | Harmonic | Coded | Other |
| Anatomy/Region of Interest | | | Doppler | Doppler | Doppler | Doppler | Doppler | Modes | Imaging | Pulse | [Notes] |
| 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 | [5,6] |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [5,6] |
| Small Organ [2] | P | P | P | P | P | P | P | P | P | P | [5,6] |
| | | | | | | | | | | | |
| 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 | [5] |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [5,6] |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | [5,6] |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other [4] | P | P | P | P | P | P | P | P | P | P | [5,6] |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | P | P | P | P | P | P | P | P | P | P | [5,6] |
| Transvaginal | P | P | P | P | P | P | P | P | P | P | [5,6] |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | P | P | P | P | P | P | P | P | P | P | [5,6] |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA;
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[5] 3D Imaging Mode
[6] Needle guidance imaging
[*] Combined modes are B/M, B/PWD, B/CF/PWD, B/PDI, B/CF/CWD, B/CWD, B/THI, and B/CMM (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
ed Dóthm G. David G. Brown
(Division Sign-Off)
Division of Raciological Device Office of In Vitro Diagnostic Device Evaluation and Sarety
510K. K192104
{7}------------------------------------------------
## GE VIVID P3 with 4C 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 | | [5,6] |
| Abdominal [1] | P | P | P | | P | P | P | P | P | | [5,6] |
| Pediatric | P | P | P | | P | P | P | P | P | | [5,6] |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [3] | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | | [5,6] |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other [4] | P | P | P | | P | P | P | P | P | | [5,6] |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; Previously cleared on GE LOGIQ P5/A5 K060993
Notes: [1] Abdominal includes renal, GYN/Pelvic ,
> . [2] Small organ includes breast, testes and thyroid.
- [3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[5] 3D Imaging Mode
[6] Needle guidance imaging
[*] Combined modes are B/M, B/PWD, B/CF/PWD, B/CF/CWD, B/CWD, B/CWD, B/TH1, and B/CMM
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
Zahad D'O'Hara for David G. Brown
(Division Sign-Off)
Division of Radiological Devices
fice of In Vitro Diagnostic Device Evaluation and Saiety
610K K102104
{8}------------------------------------------------
## GE VIVID P3 with E8Cs 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 | | [5,6] |
| Abdominal [1] | P | P | P | | P | | P | P | P | | [5,6] |
| Pediatric | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [3] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other [4] | P | P | P | | P | | P | P | P | | [5,6] |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | P | P | P | | P | | P | P | P | | [5,6] |
| Transvaginal | P | P | P | | P | | P | P | P | | [5,6] |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (Previously cleared on GE LOGIQ P5/A5 K060993);
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[5] 3D Imaging Mode
[6] Needle guidance imaging
[*] Combined modes are B/M, B/PWD, B/CF/PWD, B/PDI, B/CF/CWD, B/CWD, B/THI, and B/CMM
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
7
Prescription User (Per 21 CFR 801.109)
(Dission Sign-
Division of Radiological Devices Iffice of in vitre. Diagnostic Device Evaluation and Safety
510K K102104
{9}------------------------------------------------
## GE VIVID P3 with 8L 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] | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | P | | [5,6] |
| Small Organ [2] | P | P | P | | P | P | P | P | P | | [5,6] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [3] | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | | [5,6] |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | | [5,6] |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other [4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | P | P | P | | P | P | P | P | P | | [5,6] |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA;
Notes: {1} Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[5] 3D Imaging Mode
[6] Needle guidance imaging
[*] Combined modes are B/M, B/PWD, B/CF/PWD, B/PDI, B/CF/CWD, B/CWD, B/THI, and B/CMM
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
8
Prescription User (Per 21 CFR 801.109)
Zackary D. Knauss for David G. Brown
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K102164
,
{10}------------------------------------------------
## GE VIVID P3 with 8C 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 | | [5] |
| Pediatric | P | P | P | | P | P | P | P | P | | [5] |
| Small Organ [2] | P | P | P | | P | P | P | P | P | | [5] |
| Neonatal Cephalic | P | P | P | | P | P | P | P | P | | [5] |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [3] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other [4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA;
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes and thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[5] 3D Imaging Mode
-
[6] Needle guidance imaging
[*] Combined modes are B/M, B/PWD, B/CF/PWD, B/PD1, B/CF/CWD, B/CWD, B/THI, and B/CMM
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
James L. D'Olive
(Division Sign-Off) Gia David G. Brown
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K102104
{11}------------------------------------------------
# GE VIVID P3 with 5Cs 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 | | [5,6] | |
| Abdominal [1] | P | P | P | | P | P | P | P | P | | [5,6] | |
| Pediatric | P | P | P | | P | P | P | P | P | | [5,6] | |
| Small Organ [2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac [3] | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | | [5,6] | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other [4] | P | P | P | | P | P | P | P | P | | [5,6] | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (Previously Cleared on GE LOGIQ P5/A5 K060993);
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes and thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[5] 3D Imaging Mode
[6] Needle guidance imaging
[*] Combined modes are B/M, B/PWD, B/CF/PWD, B/CF/CWD, B/CWD, B/CWD, B/THI, and B/CMM
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
Frankl D.O'K for David G. Brown
(Division Sign-Off)
Division of Radiologica Office of In Vitro Diagnostic on and Safety
510K K102104
10
{12}------------------------------------------------
# GE VIVID P3 with 3S Transducer
Intended Use: Diagnostic uttrasound imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | | | | | |
|-------------------------------|---|-------------------|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|--------|--|
| Clinical Application | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Напполіс<br>Imaging | Coded<br>Pulse | Other | |
| Anatomy/Region of Interest | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal 1) | P | P | P | P | P | P | P | P | P | | (5,6) | |
| Pediatric | P | P | P | P | P | P | P | P | P | | (5,6) | |
| Small Organ [2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | | િર'ણ | |
| Cardiac [3] | P | P | P | P | P | P | P | b | P | | (5, 6) | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other (4) | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA;
Notes: [1] Abdominal includes renal, GYN/Pelvic
{2} Small organ includes breast, testes and thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[5] 3D Imaging Mode
[6] Needle guidance imaging
[*] Combined modes are B/M, B/PWD, B/CF/PWD, B/PDI; B/CF/CWD, B/CWD, B/THI, and B/CMM
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
PRESCRIPTION USER (PER 21 CFR 801.109) .
Indal D. O'Kee for David G. Brown
(Division Sign-Off)
and Safety
Division of Radiolo Office of In Vi
510K
11
{13}------------------------------------------------
## GE VIVID P3 with 11L 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] | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | P | | [5,6] | |
| Small Organ [2] | P | P | P | | P | P | P | P | P | | [5,6] | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac [3] | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | | [5,6] | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | | [5,6] | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other [4] | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative | P | P | P | | P | P | P | P | P | | [5,6] | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (Previously Cleared on GE LOGIQ P5/A5 K060993);
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes and thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[5] 3D Imaging Mode
[6] Needle guidance imaging
[*] Combined modes are B/M, B/PWD, B/CF/PWD, B/PDI, B/CF/CWD, B/CWD, B/THI, and B/CMM
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
PRESCRIPTION USER (PER 21 CFR 801.109)
Nuhal DSR for David G. Brow h
(Division Sign-Off)
Office of In Vitro Diagnostic Device Eva ation and Safety
510K
K102164
12
{14}------------------------------------------------
## GE VIVID P3 with T739 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 | | | | | | | | | | | |
| Abdominal [1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ [2] | P | P | P | | P | P | P | P | P | | [5] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [3] | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | | [5] |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | | [5] |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other [4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | P | P | P | | P | P | P | P | P | | [5] |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA;
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes and thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[5] 3D Imaging Mode
[6] Needle guidance imaging
[*] Combined modes are B/M, B/PWD, B/CF/PWD, B/PD1, B/CF/CWD, B/CWD, B/CWD, B/THI, and B/CMM
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
13
PRESCRIPTION USER (PER 21 CFR 801.109) ·
Division of Radiok
K102104
{15}------------------------------------------------
### GE VIVID P3 with 6S 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 | | [5] |
| Pediatric | P | P | P | P | P | P | P | P | P | | [5] |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | | [5] |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | | [5] |
| Cardiac [3] | P | P | P | P | P | P | P | P | P | | [5] |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other [4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA;
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[5] 3D Imaging Mode
[6] Needle guidance Imaging
[*] Combined modes are B/M, B/PWD, B/CF/PWD, B/CF/CWD, B/CWD, B/CWD, B/THI, and B/CMM
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
(Division Sior
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K 5102104
