# K991842: System Five/Echopac with Strain Rate Imaging

- Pathway: 510(k) (Traditional)
- Applicant: Ge Vingmed Ultrasound
- Decided: Jun 11, 1999 after 14 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: 1 generation back to K963315 (1997). 1 ancestor in all.
210 later devices descend from it; 1 cites it directly.
0 of 212 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963315: Vingmed Sound Color Flow Mapping System.  System Five, Vingmed Sound, Inc. (1997) Summary page 1.

## Most influential descendants
- K032281: Ssa-770A - Version 4, Aplio Diagnostic Ultrasound System (2003), 209 descendants of its own
- K063130: Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0 (2006), 205 descendants of its own
- K072000: Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0 (2007), 203 descendants of its own
- K072826: Aplio Artida Diagnostic Ultrasound System (2007), 182 descendants of its own
- K080160: Aplio Artida, Model SSH-880CV Diagnostic Ultrasound System (2008), 181 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/K991842
Methodology: https://510kreport.com/methodology