# K041455: Ssi-600/Ssi-800 Diagnostic Ultrasound Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Sonoscape Company Limited
- Decided: Jun 10, 2004 after 9 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 K000030 (2000). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000030: Sonoace 600 Diagnostic Ultrasound System, Medison America, Inc. (2000) Summary page 1.

## Most influential descendants
- K101337: A6 Portable Ultrasonic Diagnostic System (2010), 1 descendant of its own
- K123616: Portable Ultrasonic Diagnostic System (2012), 0 descendants of its own

## Indications for use
Ultrasonic pulsed echo imaging and measurement for fetal imaging and other abdominal as well as pediatric, small organ, cardiac.

Source page: https://510kreport.com/device/K041455
Methodology: https://510kreport.com/methodology