# K092922: Ssi-8000/S8/S6 Digital Color Doppler Ultrasound System, 2P1 Phased Array Diagnostic Ultrasound Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Sonoscape Company Limited
- Decided: Mar 12, 2010 after 170 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: 16 generations back to K935595 (1995). 116 ancestors in all.
33 later devices descend from it; 3 cite it directly.
0 of 150 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003525: Voluson 730 Diagnostic Ultrasound System, Medison America, Inc. (2000) Summary page 1.
- K092691: DC-7 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2009). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- 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
- K152854: S50 Digital Color Doppler Ultrasound System (2016), 16 descendants of its own

## Indications for use
The SonoScape SB 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/K092922
Methodology: https://510kreport.com/methodology