# K160078: Vivid T8

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Ultrasound and Primary Care Diagnotics, L
- Decided: Mar 10, 2016 after 56 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K935595 (1995). 133 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 152 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141067: Vivid T8/Vivid T8 Pro, GE Healthcare (2014) Summary page 6.
- K121063: Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound System, Ge Medical System Israel, Ltd. (2012) Summary page 6.
- K133034: Logiq F Series, GE Healthcare (2014) Summary page 6.

## Most influential descendants
- K181727: Vivid iq (2018), 9 descendants of its own
- K182277: Versana Premier (2018), 8 descendants of its own
- K200708: Vivid iq (2020), 3 descendants of its own
- K191792: Versana Balance (2019), 3 descendants of its own
- K181934: Vivid T8, Vivid T9 (2018), 3 descendants of its own

## Indications for use
The Vivid T8 is a multipurpose cardiovascular ultrasound system designed for cardiac and shared service imaging. The system supports the following applications: Fetal/lOB, Abdominal, Pediatric, Small Organ, Cardiac. Peripheral Vascular, Adult Cephalic, Neonatal Cephalic, Musculoskeletal Superficial/Conventional Transcranial, Transrectal, Transvaginal and Transesophageal.

Source page: https://510kreport.com/device/K160078
Methodology: https://510kreport.com/methodology