Vivid T8
Device Facts
| Record ID | K160078 |
|---|---|
| Device Name | Vivid T8 |
| Applicant | Ge Medical Systems Ultrasound and Primary Care Diagnotics, L |
| Product Code | IYN · Radiology |
| Decision Date | Mar 10, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The Vivid T8 is a multipurpose cardiovascular ultrasound system intended for diagnostic ultrasound imaging and fluid flow analysis. The system supports the following applications: Fetal/OB, Abdominal, Pediatric, Small Organ, Cardiac, Peripheral Vascular. Adult Cephalic. Neonatal Cephalic. Musculoskeletal Superficial/ Conventional, Transcranial, Transrectal, Transvaginal and Transesophageal.
Device Story
Vivid T8 is a mobile cardiovascular ultrasound system for diagnostic imaging and fluid flow analysis. It acquires, processes, and displays ultrasound data via a console with a keyboard, color LCD, and touch panel. It supports various clinical applications and transducers. The system includes features like 'Scan Coach' and 'Smart Start' (battery-powered). It is used by clinicians in clinical settings to visualize anatomy and blood flow, aiding in diagnostic decision-making. The device provides real-time imaging and measurements, facilitating procedures such as needle guidance. It benefits patients by providing non-invasive diagnostic information.
Clinical Evidence
No clinical data. Substantial equivalence supported by non-clinical bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety testing in compliance with standards (e.g., IEC 60601-1, IEC 60601-2-37, ISO 10993-1).
Technological Characteristics
Mobile ultrasound console with color LCD and touch panel. Operates via pulsed Doppler, B-mode, M-mode, and harmonic imaging. Complies with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2/UD 3. Patient-contact materials are biocompatible per ISO 10993-1. Connectivity includes DICOM. Software runs on Windows 7.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in fetal/OB, abdominal, pediatric, small organ (breast, testes, thyroid), cardiac (adult/pediatric), peripheral vascular, adult/neonatal cephalic, musculoskeletal (conventional/superficial), transcranial, transrectal, transvaginal, and transesophageal applications. Includes image guidance for freehand needle placement.
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
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 10, 2016
GE Medical Systems Ultrasound and Primary Care Diagnotics, LLC % Ms. Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226
Re: K160078 Trade/Device Name: Vivid T8 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 12, 2016 Received: January 14, 2016
Dear Ms. Ortiz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Oels
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if kno
K16007
Device Name
Vivid T8
Indications for Use (Describe)
The Vivid T8 is a multipupose cardiovascular ultrasound system designed for cardiac and shared service imaging. The system supports the following applications: Fetal OB, Abdominal, Pediac, Perpheral Vascular, Adult Cephalic, Neonatal Cephalic, Musculoskeletal Conventional, Transcranial, Transvaginal and Transesophageal.
Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
#### FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
PSC Publishing Services (301) 443-6740 EF
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FORM FDA 3881 (1/14)
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# Indications for Use Forms
The following forms represent indications with clinical applications and exam types along with the modes of operation for the Vivid T8. Combinations identified "P" represents those previously cleared with another GE Ultrasound system. Combinations identified as "N" are new.
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# Diagnostic Ultrasound Indications for Use Form GE Vivid T8 Diagnostic Ultrasound System
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|--------------------------------|-------------------|---|---------------|----|-------|------------|-------|---------|----------|----------|-------|-------|
| | B | M | Doppler Modes | | | | | | Combined | Harmonic | Coded | Other |
| Anatomy/Region of Interest | | | PW | CW | Color | Color<br>M | Power | Modes * | Imaging | Pulse** | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal/OB | 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 | N | 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 | |
| Thoracic/Pleural (specify) | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transcranial | P | P | P | P | P | P | P | P | P | P | P | |
| Transorbital | | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | | P | P | P | | |
| Transrectal | P | P | P | P | P | P | P | P | P | P | P | |
| Transvaginal | P | P | P | P | P | P | P | P | P | P | P | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy / Fluid Drainage | N | N | N | N | N | N | N | N | N | N | N | 4 |
N = new indication; P = previously cleared by FDA K141067; P = previously cleared by FDA K121063;
P2 = previously cleared by FDA K133034
Notes: [1] Abdominal includes GYN and Urological;
[2] Small Organ includes breast, testes, and thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Includes image guidance for freehand needle placement;
*] Combined modes are B/M, B/PWD, B/Color/PWD
[**] Coded Pulse is for digitally encoded harmonics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized script, enclosed within a circular frame. The letters and the frame are both in a blue color. The logo is simple and recognizable, representing the General Electric brand.
GE Healthcare 510(k) Premarket Notification Submission
# Diagnostic Ultrasound Indications for Use Form GE Vivid T8 with 4C-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | |
|--------------------------------|-------------------|----|---------------|--|---------------------|---------------------|------------------|-------|
| Anatomy/Region of Interest | B | M | Doppler Modes | | Combined<br>Modes * | Harmonic<br>Imaging | Coded<br>Pulse** | Other |
| Ophthalmic | | | | | | | | |
| Fetal/OB | P | P | P | | P | P | P | P |
| Abdominal [1] | P | P | P | | P | P | P | P |
| Pediatric | P1 | P1 | P1 | | P1 | P1 | P1 | P1 |
| Small Organ (specify)[2] | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac [3] | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | |
| Thoracic/Pleural (specify) | | | | | | | | |
| Other (specify) | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | |
| Transcranial | | | | | | | | |
| Transorbital | | | | | | | | |
| Transesophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Intraoperative (specify) | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Interventional Guidance | | | | | | | | |
| Tissue Biopsy / Fluid Drainage | P2 | P2 | P2 | | P2 | P2 | P2 | 4 |
N = new indication; P = previously cleared by FDA K141067; P= previously cleared by FDA K121063;
P2 = previously cleared by FDA K133034
[1] Abdominal includes GYN and Urological; Notes:
- [2] Small Organ includes breast, testes, and thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Includes image guidance for freehand needle placement;
- [*] Combined modes are B/M, B/PWD, B/Color/PWD
**] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized script, enclosed within a circular frame. The logo is colored in a light blue hue. The logo is simple and recognizable.
#### Diagnostic Ultrasound Indications for Use Form GE Vivid T8 with 8C-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|--------------------------------|-------------------|---|----|----|---------------|------------|-------|--------------------|---------------------|------------------|-------|--|
| | | | | | Doppler Modes | | | | | | | |
| Anatomy/Region of Interest | B | M | PW | CW | Color | Color<br>M | Power | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse** | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal/OB | | | | | | | | | | | | |
| Abdominal [1] | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | | P | P | P | P | | |
| Small Organ (specify)[2] | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | | P | P | P | P | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac [3] | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | | P | P | P | P | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Thoracic/Pleural (specify) | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | |
| Transorbital | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy / Fluid Drainage | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K141067; P1= previously cleared by FDA K121063;
P2 = previously cleared by FDA K133034
[1] Abdominal includes GYN and Urological; Notes:
[2] Small Organ includes breast, testes, and thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Includes image guidance for freehand needle placement;
[*] Combined modes are B/M, B/PWD, B/Color/PWD
[**] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
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Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized script, enclosed within a circular frame. The logo is colored in a light blue hue. The logo is simple and recognizable.
## Diagnostic Ultrasound Indications for Use Form
### GE Vivid T8 with E8C-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|-----------------------------------|-------------------|----|----|----|---------------|---------|-------|---------------------|---------------------|------------------|---|-------|
| | | M | | | Doppler Modes | | | | | | | Other |
| <i>Anatomy/Region of Interest</i> | B | | PW | CW | Color | Color M | Power | Combined<br>Modes * | Harmonic<br>Imaging | Coded<br>Pulse** | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal/OB | P | P | P | | P | | P | P | P | P | | |
| Abdominal[1] | P | P | P | | P | | P | P | P | P | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (specify)[2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac [3] | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Thoracic/Pleural (specify) | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |
| <i>Exam Type, Means of Access</i> | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | |
| Transorbital | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | P | P | P | | P | | P | P | P | P | | |
| Transvaginal | P | P | P | | P | | P | P | P | P | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| <i>Interventional Guidance</i> | | | | | | | | | | | | |
| Tissue Biopsy / Fluid Drainage | P² | P² | P² | | P² | | P² | P² | P² | P² | 4 | |
N = new indication; P = previously cleared by FDA K141067; P = previously cleared by FDA K121063;
P2 = previously cleared by FDA K133034
[1] Abdominal includes GYN and Urological; Notes:
[2] Small Organ includes breast, testes, and thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Includes image guidance for freehand needle placement;
- [*] Combined modes are B/M, B/PWD, B/Color/PWD
- [**] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
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Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a circular frame. The logo is colored in blue, with the letters and the frame in the same shade of blue.
## Diagnostic Ultrasound Indications for Use Form
#### GE Vivid T8 with 3Sc-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | |
|--------------------------------|-------------------|----|---------------|----|----|----|--------------------|---------------------|------------------|-------|---|
| Anatomy/Region of Interest | B | M | Doppler Modes | | | | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse** | Other | |
| Ophthalmic | | | | | | | | | | | |
| Fetal/OB | | | | | | | | | | | |
| 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] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| 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 | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural (specify) | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | P | P | P | P | P | P | P | P | P | P | P |
| Transorbital | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy / Fluid Drainage | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | 4 |
N = new indication; P = previously cleared by FDA K141067; P= previously cleared by FDA K121063;
P2 = previously cleared by FDA K133034
[1] Abdominal includes GYN and Urological; Notes:
- [2] Small Organ includes breast, testes, and thyroid;
- [3] Cardiac is Adult and Pediatric;
- [4] Includes image guidance for freehand needle placement;
- [*] Combined modes are B/M, B/PWD, B/Color/PWD
- ** ] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized script, enclosed within a circular frame. The letters and the frame are both in a blue color. The logo is simple and recognizable, representing the General Electric brand.
## Diagnostic Ultrasound Indications for Use Form
#### GE Vivid T8 with 6S-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|--------------------------------|-------------------|---|----------------|---|------------|---------------|-------------------|---------|---------|-------|--|--|
| | | | | | | Doppler Modes | Combined Harmonic | Coded | | | | |
| Anatomy/Region of Interest | B | M | PW<br>CW Color | | Color<br>M | Power | Modes* | Imaging | Pulse** | Other | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal/OB | P | P | P | P | P | P | | P | P | P | | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | | |
| Pediatric | P | P | P | P | P | P | | P | P | P | | |
| Small Organ (specify)[2] | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiacl3] | P | P | P | P | P | P | | P | P | P | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Thoracic/Pleural (specify) | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | |
| Transorbital | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy / Fluid Drainage | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K141067; P = previously cleared by FDA K121063;
P2 = previously cleared by FDA K133034
[1] Abdominal includes GYN and Urological; Notes:
[2] Small Organ includes breast, testes, and thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Includes image guidance for freehand needle placement;
- [*] Combined modes are B/M, B/PWD, B/Color/PWD
[**] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular shape. The color of the logo is blue, and the background is white.
# Diagnostic Ultrasound Indications for Use Form
### GE Vivid T8 with 12S-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | |
|--------------------------------|-------------------|----|----|----|------------------------|---------|-------|--------------------|---------------------|------------------|-------|
| Anatomy/Region of Interest | B | M | PW | CW | Doppler Modes<br>Color | Color M | Power | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse** | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal/OB | | | | | | | | | | | |
| Abdominal[1] | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | N |
| Pediatric | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | N |
| Small Organ (specify)[2] | | | | | | | | | | | |
| Neonatal Cephalic | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | N |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | N |
| Peripheral Vascular | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | N |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural (specify) | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transorbital | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy / Fluid Drainage | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K141067; P1= previously cleared by FDA K121063;
P2 = previously cleared by FDA K133034
[1] Abdominal includes GYN and Urological; Notes:
[2] Small Organ includes breast, testes, and thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Includes image guidance for freehand needle placement;
- [*] Combined modes are B/M, B/PWD, B/Color/PWD
**] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular shape. The color of the logo is blue, and the background is white.
# Diagnostic Ultrasound Indications for Use Form
#### GE Vivid T8 with 6Tc-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | |
|-----------------------------------|-------------------|---|---------------|----|-------|------------|-------|--------------------|---------------------|------------------|-------|
| Anatomy/Region of Interest | B | M | Doppler Modes | | | | | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse** | Other |
| | | | PW | CW | Color | Color<br>M | Power | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal/OB | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify)[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | P | P | P | P | P | P | | P | P | P | P |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural (specify) | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| <i>Exam Type, Means of Access</i> | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transorbital | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | | P | P | P | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy / Fluid Drainage | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K141067; P= previously cleared by FDA K121063;
P2 = previously cleared by FDA K133034
Notes: [1] Abdominal includes GYN and Urological;
[2] Small Organ includes breast, testes, and thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Includes image guidance for freehand needle placement;
* | Combined modes are B/M, B/PWD, B/Color/PWD
* ] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular shape. The color of the logo is blue, and the background is white.
# Diagnostic Ultrasound Indications for Use Form
### GE Vivid T8 with P2D Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | |
|--------------------------------|-------------------|---|----|----|---------------|------------|-------|--------------------|---------|---------------|-------|
| | | M | | | Doppler Modes | | | | | | |
| Anatomy/Region of Interest | B | | PW | CW | Color | Color<br>M | Power | Combined Harmonic* | Imaging | Coded Pulse** | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal/OB | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify)[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | P | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural (specify) | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transorbital | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Interventional Guidanceof | | | | | | | | | | | |
| Tissue Biopsy / Fluid Drainage | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K141067; P = previously cleared by FDA K121063;
P2 = previously cleared by FDA K133034
[1] Abdominal includes GYN and Urological; Notes:
[2] Small Organ includes breast, testes, and thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Includes image guidance for freehand needle placement;
- [*] Combined modes are B/M, B/PWD, B/Color/PWD
[**] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular shape. The logo is colored in blue, with the letters and the surrounding circle being the same shade of blue.
# Diagnostic Ultrasound Indications for Use Form
#### GE Vivid T8 with L6-12-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | | |
|--------------------------------|-------------------|---|----|----|---------------|------------|-------|----|----|---------------------|---------------------|------------------|-------|
| | | | | | Doppler Modes | | | | | Combined<br>Modes * | Harmonic<br>Imaging | Coded<br>Pulse** | Other |
| Anatomy/Region of Interest | B | M | PW | CW | Color | Color<br>M | Power | | | | | | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal/OB | | | | | | | | | | | | | |
| Abdominal[1] | P | P | P | | P | | P | P | P | P | P | | |
| Pediatric | 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 | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | | | |
| Peripheral Vascular | 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 | | |
| Thoracic/Pleural (specify) | | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | | |
| Transorbital | | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | | |
| Tissue Biopsy / Fluid Drainage | P2 | | P2 | | P2 | | P2 | P2 | P2 | P2 | | 4 | |
N = new indication; P = previously cleared by FDA K141067; P= previously cleared by FDA K121063;
P2 = previously cleared by FDA K133034
[1] Abdominal includes GYN and Urological; Notes:
- [2] Small Organ includes breast, testes, and thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Includes image guidance for freehand needle placement;
- [*] Combined modes are B/M, B/PWD, B/Color/PWD
[**] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{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 in a stylized script, enclosed within a circular frame. The logo is colored in a light blue hue, and the background is white.
## Diagnostic Ultrasound Indications for Use Form
### GE Vivid T8 with 9L-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | |
|--------------------------------|-------------------|----|---------------|----|-------|---------|-------|--------------------|---------------------|------------------|-------|
| | | | Doppler Modes | | | | | | | | |
| Anatomy/Region of Interest | B | M | PW | CW | Color | Color M | Power | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse** | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal/OB | | | | | | | | | | | |
| Abdominal[1] | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | |
| Pediatric | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | |
| Small Organ (specify)[2] | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N | N |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | |
| Musculo-skeletal Conventional | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | |
| Musculo-skeletal Superficial | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | |
| Thoracic/Pleural (specify) | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transorbital | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Interventional Guidanceof | | | | | | | | | | | |
| Tissue Biopsy / Fluid Drainage | N | N | N | N | N | N | N | N | N | N | 4 |
N = new indication; P = previously cleared by FDA K141067; P= previously cleared by FDA K121063;
P2 = previously cleared by FDA K133034
[1] Abdominal includes GYN and Urological; Notes:
[2] Small Organ includes breast, testes, and thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Includes image guidance for freehand needle placement;
- [*] Combined modes are B/M, B/PWD, B/Color/PWD
[**] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{16}------------------------------------------------
Image /page/16/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a circular shape. The logo is colored in blue, with the letters and the surrounding circle being the same shade of blue.
# Diagnostic Ultrasound Indications for Use Form
## GE Vivid T8 with 12L-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | |
|--------------------------------|-------------------|----|---------------|----|-------|---------|-------|--------------------|---------------------|------------------|-------|
| Anatomy/Region of Interest | B | M | Doppler Modes | | | | | | | | |
| | | | PW | CW | Color | Color M | Power | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse** | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal/OB | | | | | | | | | | | |
| Abdominal[1] | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | |
| Pediatric | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | |
| Small Organ (specify)[2] | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | |
| Musculo-skeletal Conventional | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | |
| Musculo-skeletal Superficial | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | P¹ | |
| Thoracic/Pleural (specify) | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transorbital | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Interventional Guidanceof | | | | | | | | | | | |
| Tissue Biopsy / Fluid Drainage | N | N | N | N | N | N | N | N | N | N | 4 |
N = new indication; P = previously cleared by FDA K141067; P = previously cleared by FDA K121063;
P2 = previously cleared by FDA K133034
[1] Abdominal includes GYN and Urological; Notes:
[2] Small Organ includes breast, testes, and thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Includes image guidance for freehand needle placement;
- [*] Combined modes are B/M, B/PWD, B/Color/PWD
[**] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
#### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{17}------------------------------------------------
Image /page/17/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. There are swirling designs around the letters. The logo is simple and recognizable.
# 510(k) Summary
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | January 12, 2016…
