# K051449: GE Vivid 7 with or Without Suffix

- Pathway: 510(k) (Special)
- Applicant: GE Medical Systems
- Decided: Jun 16, 2005 after 14 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: 3 generations back to K003931 (2001). 3 ancestors in all.
704 later devices descend from it; 3 cite it directly.
0 of 708 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003931: Vivid 7 with Sonopac, Model FB0008XX, Ge Medical Systems, Inc. (2001) Summary page 1.
- K041552: GE Vivid 7 BT04, General Electric Co. (2004) Summary page 1.

## Most influential descendants
- K060542: GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XX (2006), 689 descendants of its own
- K080223: Zura Tee System (2008), 583 descendants of its own
- K083095: Sonixtouch Ultrasound System (2008), 582 descendants of its own
- K081921: GE Vivid E9 Ultrasound (2008), 579 descendants of its own
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 (2009), 569 descendants of its own

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

Source page: https://510kreport.com/device/K051449
Methodology: https://510kreport.com/methodology