← Product Code [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN) · K181934
# Vivid T8, Vivid T9 (K181934)
_GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · IYN · Nov 6, 2018 · Radiology · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K181934
## Device Facts
- **Applicant:** GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
- **Product Code:** [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN.md)
- **Decision Date:** Nov 6, 2018
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1550
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** Pediatric
## Intended Use
The Vivid T9 / Vivid T8 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Fetal/OB, Abdominal, Pediatric, Small Organ, Cardiac, Peripheral Vascular, Adult Cephalic, Neonatal Cephalic, Musculoskeletal Superficial/Conventional, Transrectal, Transvaginal, Transesophageal, Intraoperative and Tissue Biopsy.
## Device Story
Vivid T8/T9 are high-performance digital ultrasound imaging systems. They acquire ultrasound signals via various transducers to generate 2D (B) mode, M-mode, Color M-mode, Color Doppler, Power Doppler (PDI), and spectral PW/CW Doppler images. The system supports advanced applications including Tissue Velocity imaging, Strain/Strain Rate, Cardiac AutoDoppler, Virtual Apex, Virtual Convex, and QuickApps. Used in clinical settings by healthcare professionals for diagnostic imaging, measurement, and analysis. Output is displayed for clinician review to support diagnostic decision-making. Features include Tricefy Uplink for data management and improved AFI/Auto EF tools. The system provides image guidance for freehand needle placement during tissue biopsy and fluid drainage.
## Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including acoustic output measurements, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety testing in compliance with AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, and ISO10993-1.
## Technological Characteristics
Digital ultrasound system supporting B, M, Color M, Color Doppler, PDI, and PW/CW Doppler modes. Compatible with various RS-series transducers. Connectivity includes DICOM. Safety standards: AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, NEMA UD 2. Biocompatible patient-contact materials. Software features include Strain/Strain Rate, Auto EF, AFI, and Tricefy Uplink.
## Regulatory Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
## Predicate Devices
- Vivid T8 ([K160078](/device/K160078.md))
- Vivid E95 ([K170823](/device/K170823.md))
- Vivid iq ([K161706](/device/K161706.md))
- Vscan Extend ([K180995](/device/K180995.md))
- LOGIQ e ([K151028](/device/K151028.md))
- LOGIQ P9 and LOGIQ P7 ([K163596](/device/K163596.md))
## Submission Summary (Full Text)
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November 6, 2018
GE Medical Systems Ultrasound & Primary Care Diagnostics LLC Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA, WI 53226
Re: K181934
Trade/Device Name: Vivid T8, Vivid T9 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: November 1, 2018 Received: November 2, 2018
Dear Tracey 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Hole 2. Nils
for Robert A. 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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## Indications for Use
510(k) Number (if known)
K181934
Device Name Vivid T8, Vivid T9
#### Indications for Use (Describe)
The Vivid T9 / Vivid T8 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Fetal/OB, Abdominal, Pediatric, Small Organ, Cardiac, Peripheral Vascular, Adult Cephalic, Neonatal Cephalic, Musculosketal Superficial/Conventional, Transrectal, Transvaginal, Transesophageal, Intraoperative and Tissue Biopsy.
| 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)
|
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## GE Healthcare 510(k) Premarket Notification Submission
## 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 and Vivid T9. Combinations identified "P" represents those previously cleared with another GE Ultrasound system. Combinations identified as "N" are new.
The following Indication for Use forms are appended:
System: Vivid T8, Vivid T9 Transducer: 4C-RS Transducer: 8C-RS Transducer: E8C-RS Transducer: 3Sc-RS Transducer: 6S-RS Transducer: 12S-RS Transducer: 6Tc-RS Transducer: P2D Transducer: L6-12-RS Transducer: 9L-RS Transducer: 12L-RS Transducer: 9T-RS Transducer: L8-18i-RS Transducer: C1-5-RS (Only for Vivid T9) Transducer: E8Cs-RS (Only for Vivid T9)
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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized, cursive font, enclosed within a circular frame. The letters and the frame are both in a shade of blue, and the background is white.
510(k) Premarket Notification Submission
### GE Vivid T8 / Vivid T9 Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|---------|-----|----------------------|---------------------|--------------------|-------|--|
| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M | PDI | Combined
Modes[*] | Harmonic
Imaging | Coded
Pulse[**] | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | P | |
| Abdominal [1] | P | P | P | P | P | P | P | P | P | P | P | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | P | |
| Small Organ [2] | P | P | P | P | P | P | P | P | P | P | P | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | P | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | P | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | P | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | P | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | P | P | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transcranial | P | P | P | P | P | P | P | P | P | P | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | P | | |
| Transrectal | P | P | P | P | P | P | P | P | P | P | | |
| Transvaginal | P | P | P | P | P | P | P | P | P | P | | |
| Intraoperative [4] | N | N | N | N | N | N | N | N | N | N | N | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy / Fluid
Drainage [5] | P | | | | P | | P | | P | | | |
N= new indication; P= previously cleared by FDA K160078; P1= previously cleared by FDA K151028. P= previously cleared by FDA K161706. P3= previously cleared by FDA K163596.
Notes: [1] Abdominal includes GYN and Urological;
[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Intraoperative includes abdominal, thoracic and peripheral;
[5] Includes image guidance for freehand needle placement;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD
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Image /page/5/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 blue circle. The letters are white, creating a contrast against the blue background of the circle.
GE Healthcare 510(k) Premarket Notification Submission
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|----|---------------|---------------|------------------|---------|-----|----------------------|---------------------|--------------------|-------|--|
| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M | PDI | Combined
Modes[*] | Harmonic
Imaging | Coded
Pulse[**] | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | | P | | P | P | P | P | | |
| Abdominal [1] | P | P | P | | P | | P | P | P | P | | |
| Pediatric | P | P | P | | P | | P | P | P | P | | |
| Small Organ [2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | P1 | P1 | P1 | | P1 | N | P1 | P1 | P1 | P1 | | |
| Musculo-skeletal Superficial | P1 | P1 | P1 | | P1 | N | P1 | P1 | P1 | P1 | | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy / Fluid
Drainage [5] | P | | | | P | | P | | P | | | |
### GE Vivid T8 / Vivid T9 with 4C-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication; P= previously cleared by FDA K160078; P1= previously cleared by FDA K151028. P2= previously cleared by FDA K161706. P3= previously cleared by FDA K163596.
Notes: [1] Abdominal includes GYN and Urological;
[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Intraoperative includes abdominal, thoracic and peripheral;
[5] Includes image guidance for freehand needle placement;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD
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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' in a stylized, cursive font, enclosed within a blue circle. The letters are white, creating a contrast against the blue background of the circle.
GE Healthcare 510(k) Premarket Notification Submission
| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M | PDI | Combined
Modes[*] | Harmonic
Imaging | Coded
Pulse[**] | Other |
|----------------------------------------------------|----|----|---------------|---------------|------------------|---------|-----|----------------------|---------------------|--------------------|-------|
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal [1] | P | P | P | | P | P2 | P | P | P | P | |
| Pediatric | P | P | P | | P | P2 | P | P | P | P | |
| Small Organ [2] | P1 | P1 | P1 | | P1 | N | P1 | P1 | P1 | P1 | |
| Neonatal Cephalic | P | P | P | | P | P2 | P | P | P | P | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | P1 | P1 | P1 | | P1 | P2 | P1 | P1 | P1 | P1 | |
| Peripheral Vascular | P | P | P | | P | P2 | P | P | P | P | |
| Musculo-skeletal Conventional | P1 | P1 | P1 | | P1 | N | P1 | P1 | P1 | P1 | |
| Musculo-skeletal Superficial | P1 | P1 | P1 | | P1 | N | P1 | P1 | P1 | P1 | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | P3 | P3 | P3 | | P3 | P3 | P3 | P3 | P3 | P3 | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy / Fluid
Drainage [5] | | | | | | | | | | | |
### GE Vivid T8 / Vivid T9 with 8C-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication; P= previously cleared by FDA K160078; P1= previously cleared by FDA K151028. P2= previously cleared by FDA K161706. P3= previously cleared by FDA K163596.
Notes: [1] Abdominal includes GYN and Urological;
[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Intraoperative includes abdominal, thoracic and peripheral;
[5] Includes image guidance for freehand needle placement;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD
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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' in a stylized, cursive font, enclosed within a circular shape. The letters and the circle are in a blue color, set against a white background.
510(k) Premarket Notification Submission
### GE Vivid T8 / Vivid T9 with E8C-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|---------|-----|----------------------|---------------------|--------------------|-------|
| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M | PDI | Combined
Modes[*] | Harmonic
Imaging | Coded
Pulse[**] | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | | P | P3 | P | P | P | P | |
| Abdominal [1] | P | P | P | | P | P3 | P | P | P | P | |
| Pediatric | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | P | P | P | | P | P3 | P | P | P | P | |
| Transvaginal | P | P | P | | P | P3 | P | P | P | P | |
| Intraoperative [4] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy / Fluid
Drainage[5] | P | | | | P | | P1 | | P | | |
N= new indication; P= previously cleared by FDA K160078; P = previously cleared by FDA K151028. P = previously cleared by FDA K161706. P3= previously cleared by FDA K163596.
[1] Abdominal includes GYN and Urological; Notes:
- [2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Intraoperative includes abdominal, thoracic and peripheral;
[5] Includes image guidance for freehand needle placement;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD
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Image /page/8/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 shape, and the entire logo is colored in a shade of blue.
510(k) Premarket Notification Submission
### GE Vivid T8 / Vivid T9 with 3Sc-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|----|---------------|---------------|------------------|---------|-----|----------------------|---------------------|--------------------|-------|
| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M | PDI | Combined
Modes[*] | Harmonic
Imaging | Coded
Pulse[**] | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | | |
| Abdominal [1] | P | P | P | P | P | P | P | P | P | | |
| Pediatric | P | P | P | P | P | P | P | P | P | | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | P | P | P | P | P | P | P | P | P | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy / Fluid
Drainage[5] | P | | | | P | | | | P | | |
N= new indication; P= previously cleared by FDA K160078; P = previously cleared by FDA K151028. P = previously cleared by FDA K161706. P3= previously cleared by FDA K163596.
[1] Abdominal includes GYN and Urological; Notes:
- [2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Intraoperative includes abdominal, thoracic and peripheral;
[5] Includes image guidance for freehand needle placement;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD
{9}------------------------------------------------
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, cursive font, enclosed within a circular frame. The letters and the frame are both in a shade of blue, and the background is white.
510(k) Premarket Notification Submission
### GE Vivid T8 / Vivid T9 with 6S-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|----|---------------|---------------|------------------|---------|-----|----------------------|---------------------|--------------------|-------|
| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M | PDI | Combined
Modes[*] | Harmonic
Imaging | Coded
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 | P2 | P | P | | |
| Small Organ [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] | P | P | P | P | P | P | P | P | P | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy / Fluid
Drainage[5] | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA K160078; P = previously cleared by FDA K151028. P = previously cleared by FDA K161706. P3= previously cleared by FDA K163596.
[1] Abdominal includes GYN and Urological; Notes:
- [2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Intraoperative includes abdominal, thoracic and peripheral;
[5] Includes image guidance for freehand needle placement;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD
{10}------------------------------------------------
Image /page/10/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 shape. The letters and the circle are in a blue color, set against a white background.
510(k) Premarket Notification Submission
### GE Vivid T8 / Vivid T9 with 12S-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|----|---------------|---------------|------------------|---------|-----|----------------------|---------------------|--------------------|-------|
| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M | PDI | Combined
Modes[*] | Harmonic
Imaging | Coded
Pulse[**] | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal [1] | P | P | P | P | P | P | P | P | P | | |
| Pediatric | P | P | P | P | P | P | P2 | P | P | | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy / Fluid
Drainage[5] | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA K160078; P = previously cleared by FDA K151028. P = previously cleared by FDA K161706. P3= previously cleared by FDA K163596.
[1] Abdominal includes GYN and Urological; Notes:
- [2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Intraoperative includes abdominal, thoracic and peripheral;
[5] Includes image guidance for freehand needle placement;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD
{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 enclosed within a circular shape, and the entire logo is colored in a shade of blue.
510(k) Premarket Notification Submission
### GE Vivid T8 / Vivid T9 with 6Tc-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|---------|-----|----------------------|---------------------|--------------------|-------|
| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M | PDI | Combined
Modes[*] | Harmonic
Imaging | Coded
Pulse[**] | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal [1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | P | P | P | P | P | P | | P | P | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | | P | P | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy / Fluid
Drainage[5] | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA K160078; P = previously cleared by FDA K151028. P = previously cleared by FDA K161706. P3= previously cleared by FDA K163596.
[1] Abdominal includes GYN and Urological; Notes:
- [2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Intraoperative includes abdominal, thoracic and peripheral;
[5] Includes image guidance for freehand needle placement;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD
{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 in a stylized, cursive font. The letters are enclosed within a circular shape, and the entire logo is colored in a shade of blue.
510(k) Premarket Notification Submission
### GE Vivid T8 / Vivid T9 with P2D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|---------|-----|----------------------|---------------------|--------------------|-------|--|
| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M | PDI | Combined
Modes[*] | Harmonic
Imaging | Coded
Pulse[**] | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal [1] | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[3] | | | | P | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy / Fluid
Drainage[5] | | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA K160078; P = previously cleared by FDA K151028. P = previously cleared by FDA K161706. P3= previously cleared by FDA K163596.
[1] Abdominal includes GYN and Urological; Notes:
- [2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Intraoperative includes abdominal, thoracic and peripheral;
[5] Includes image guidance for freehand needle placement;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized, cursive font, enclosed within a circular frame. The letters and the frame are both in a shade of blue, and the background is white.
510(k) Premarket Notification Submission
### GE Vivid T8 / Vivid T9 with L6-12-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|---------|-----|----------------------|---------------------|--------------------|-------|--|
| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M | PDI | Combined
Modes[*] | Harmonic
Imaging | Coded
Pulse[**] | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal [1] | P | P | P | | P | | P | P | P | P | | |
| Pediatric | P | P | P | | P | | P | P | P | P | | |
| Small Organ [2] | P | P | P | | P | | P | P | P | P | | |
| Neonatal Cephalic | P | P | P | | P | | P | P | P | P | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | | P | P | P | P | | |
| Musculo-skeletal Conventional | P | P | P | | P | | P | P | P | P | | |
| Musculo-skeletal Superficial | P | P | P | | P | | P | P | P | P | | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy / Fluid
Drainage[5] | P | | | P | P | | P | | P | | | |
N= new indication; P= previously cleared by FDA K160078; P = previously cleared by FDA K151028. P = previously cleared by FDA K161706. P3= previously cleared by FDA K163596.
[1] Abdominal includes GYN and Urological; Notes:
[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Intraoperative includes abdominal, thoracic and peripheral;
[5] Includes image guidance for freehand needle placement;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD
{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, cursive font, enclosed within a circular frame. The letters and the frame are both in a blue color. The logo is simple and recognizable, representing the well-known multinational corporation.
510(k) Premarket Notification Submission
### GE Vivid T8 / Vivid T9 with 9L-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|---------|-----|----------------------|---------------------|--------------------|-------|--|
| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M | PDI | Combined
Modes[*] | Harmonic
Imaging | Coded
Pulse[**] | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal [1] | P | P | P | P | P | P | P | P | P | P | | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | | |
| Small Organ [2] | P | P | P | P | P | P | P | P | P | P | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | P | | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy / Fluid
Drainage[5] | P | | | | P | | P | | P | | | |
N= new indication; P= previously cleared by FDA K160078; P = previously cleared by FDA K151028. P = previously cleared by FDA K161706. P3= previously cleared by FDA K163596.
[1] Abdominal includes GYN and Urological; Notes:
- [2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Intraoperative includes abdominal, thoracic and peripheral;
[5] Includes image guidance for freehand needle placement;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD
{15}------------------------------------------------
Image /page/15/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 both in a blue color. The logo is simple and recognizable, representing the well-known multinational corporation.
510(k) Premarket Notification Submission
### GE Vivid T8 / Vivid T9 with 12L Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|---------|-----|----------------------|---------------------|--------------------|-------|
| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M | PDI | Combined
Modes[*] | Harmonic
Imaging | Coded
Pulse[**] | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal [1] | P | P | P | | P | | P | P | P | P | |
| Pediatric | P | P | P | | P | | P | P | P | P | |
| Small Organ [2] | P | P | P | | P | | P | P | P | P | |
| Neonatal Cephalic | P | P | P | | P | | P | P | P | P | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | | P | P | P | P | |
| Musculo-skeletal Conventional | P | P | P | | P | | P | P | P | P | |
| Musculo-skeletal Superficial | P | P | P | | P | | P | P | P | P | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | |…
---
**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K181934](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K181934)
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