# K101149: GE Vivid E9 Diagnostic Ultrasound Imaging System

- Pathway: 510(k) (Special)
- Applicant: Ge Vingmed Ultrasound AS
- Decided: Oct 13, 2010 after 173 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K003931 (2001). 6 ancestors in all.
350 later devices descend from it; 4 cite it directly.
0 of 357 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081921: GE Vivid E9 Ultrasound, General Electric Co. (2008) Summary page 1.

## Most influential descendants
- K120201: GE Vivid E9 Diagnostic Ultrasound Imaging System (2012), 253 descendants of its own
- K131527: Logiq S8 (2013), 219 descendants of its own
- K121063: Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound System (2012), 176 descendants of its own
- K131514: GE Vivid E9 Diagnostic Ultrasound Imaging System (2013), 167 descendants of its own
- K133034: Logiq F Series (2014), 155 descendants of its own

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K101149
Methodology: https://510kreport.com/methodology