# K042369: Sonoscape Ultrasound System Ssi-1000/Ssi-5000

- Pathway: 510(k) (Traditional)
- Applicant: Sonoscape Company Limited
- Decided: Oct 20, 2004 after 50 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 K933202 (1994). 4 ancestors in all.
40 later devices descend from it; 3 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970901: GE Logiq 500 Diagnostic Ultrasound System, GE Medical Systems (1997) Summary page 1.
- K991611: GE Logiq 500, General Electric Co. (1999) Summary page 1.
- K010329: LOGIQ 500, General Electric Co. (2001) Summary page 1.

## Most influential descendants
- K052042: Sonoscape Ssi-1000/Ssi-5000 Ultrasound Transducers (2005), 33 descendants of its own
- K102642: Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1 Phased Array, 5P1 Phased Array Model 2P1, 5P1, 6V1 Micro (2011), 29 descendants of its own
- K132527: Digital Color Doppler Ultasound System (2013), 28 descendants of its own
- K142710: S9 Portable Digital Color Doppler Ultrasound System (2015), 19 descendants of its own
- K150045: S30/S40 Digital Color Doppler Ultraound System (2015), 17 descendants of its own

## Indications for use
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen; Pediatric; Small Organ (breast, tests, thyroid); heart soft tissue; Peripheral Vascular, Musculo-skeletal (conventional) and Urology.

Source page: https://510kreport.com/device/K042369
Methodology: https://510kreport.com/methodology