# K141067: Vivid T8/Vivid T8 Pro

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: May 23, 2014 after 29 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: 18 generations back to K935595 (1995). 132 ancestors in all.
19 later devices descend from it; 1 cites 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)
- K121063: Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound System, Ge Medical System Israel, Ltd. (2012) Summary page 1.
- K133034: Logiq F Series, GE Healthcare (2014) Summary page 1.

## Most influential descendants
- K160078: Vivid T8 (2016), 18 descendants of its own
- 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

## Indications for use
The Vivid TB/Vivid T8 Pro is Multipurpose Cardiovascular System designed for cardiac and Shared Service Imaging, the system supports following applications: Fetal/OB, 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/K141067
Methodology: https://510kreport.com/methodology