# K963315: Vingmed Sound Color Flow Mapping System.  System Five

- Pathway: 510(k) (Traditional)
- Applicant: Vingmed Sound, Inc.
- Decided: Mar 17, 1997 after 207 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
No predicates in its family tree.
405 later devices descend from it; 2 cite it directly.
3 of 406 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
- K981397: Harmonic Imaging and Flash Echo Imaging Function for the Diagnostic Ultrasound System Ssa-380A, Powervision 7000 (1998), 403 descendants of its own
- K991858: Ssa-390A/Power Vision 8000 (1999), 212 descendants of its own
- K013633: Ssa-770A, Aplio Ultrasound System (2001), 211 descendants of its own
- K022400: Ssa-700A, Aplio Diagnostic Ultrasound System (2002), 210 descendants of its own
- K991842: System Five/Echopac with Strain Rate Imaging (1999), 210 descendants of its own

Source page: https://510kreport.com/device/K963315
Methodology: https://510kreport.com/methodology