# K181934: Vivid T8, Vivid T9

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
- Decided: Nov 6, 2018 after 110 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: 22 generations back to K935595 (1995). 275 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 279 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160078: Vivid T8, Ge Medical Systems Ultrasound and Primary Care Diagnotics, L (2016) Summary page 5.
- K170823: Vivid E80, Vivid E90, Vivid E95, GE Medical Systems Ultrasound and Primary Care Diagnostics (2017) Summary page 21.
- K161706: Vivid iq, Ge Medical Systems Ultrasound and Primary Care Diagnostics L (2016) Summary page 5.
- K180995: Vscan Extend, GE Medical Systems Ultrasound and Primary Care Diagnostics (2018) Summary page 21.
- K151028: LOGIQ e, GE Medical Systems Ultrasound and Primary Care Diagnostics (2015) Summary page 5.
- K163596: LOGIQ P9 and LOGIQ P7, GE Healthcare (2017) Summary page 5.

## Most influential descendants
- K200851: Vivid T8, Vivid T9 (2020), 2 descendants of its own
- K221147: Vivid T8, Vivid T9 (2022), 1 descendant of its own
- K243628: Vivid T9/Vivid T8 (2025), 0 descendants of its own

## Indications for 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, Transcranial, Transrectal, Transvaginal, Transesophageal, Intraoperative and Tissue Biopsy.

Source page: https://510kreport.com/device/K181934
Methodology: https://510kreport.com/methodology