# K102642: Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1 Phased Array, 5P1 Phased Array Model 2P1, 5P1, 6V1 Micro

- Pathway: 510(k) (Traditional)
- Applicant: Sonoscape Company Limited
- Decided: Mar 4, 2011 after 172 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). 119 ancestors in all.
29 later devices descend from it; 1 cites it directly.
0 of 149 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092691: DC-7 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2009) Summary page 1.
- K052042: Sonoscape Ssi-1000/Ssi-5000 Ultrasound Transducers, Sonoscape Company Limited (2005) Summary page 1.
- K092922: Ssi-8000/S8/S6 Digital Color Doppler Ultrasound System, 2P1 Phased Array Diagnostic Ultrasound Transducer, Sonoscape Company Limited (2010) Summary page 1.

## Most influential descendants
- 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
- K160283: S45 Digital Color Doppler Ultrasound System (2016), 15 descendants of its own

## Indications for use
The SonoScape SSI-8000 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Trans-esoph (Cardiac), Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Urology and OB/Gyn.

Source page: https://510kreport.com/device/K102642
Methodology: https://510kreport.com/methodology