# K003931: Vivid 7 with Sonopac, Model FB0008XX

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems, Inc.
- Decided: Jan 18, 2001 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
No predicates in its family tree.
1,004 later devices descend from it; 5 cite it directly.
2 of 1,005 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K031663: GE Vivid 7, Model FC0003XX (2003), 1,003 descendants of its own
- K041552: GE Vivid 7 BT04 (2004), 996 descendants of its own
- K051139: Acuson Sequoia Diagnostic Ultrasound System (2005), 979 descendants of its own
- K052410: Acuson Sequoia Ultrasound System (2005), 972 descendants of its own
- K063085: Modification to Acuson Sequoia Ultrasound System (2006), 838 descendants of its own

Source page: https://510kreport.com/device/K003931
Methodology: https://510kreport.com/methodology