# K112451: S8 Diagnostic Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Sonoscape Company Limited
- Decided: Sep 16, 2011 after 22 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: 17 generations back to K935595 (1995). 117 ancestors in all.
No later device cites it as a predicate yet.
0 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092922: Ssi-8000/S8/S6 Digital Color Doppler Ultrasound System, 2P1 Phased Array Diagnostic Ultrasound Transducer, Sonoscape Company Limited (2010) Summary page 1.

## Indications for use
The SonoScape S8 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thyroid), Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, OB/Gyn and Urology.

Source page: https://510kreport.com/device/K112451
Methodology: https://510kreport.com/methodology