# Sonoscape Company Limited

- Location (FDA's records): Shenzhen, Guangdong, CN
- FDA decisions: 22 (2004–2015): 22 510(k) clearances
- Product codes: IYN (18), IYO (3), DPS (1)
- Predicates its devices cite: 43 (24 its own); citations of its devices by later devices: 41 (24 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Philips Ultrasound, Inc.: 6 (https://510kreport.com/company/philips-ultrasound)
- General Electric Co.: 4 (https://510kreport.com/company/general-electric)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 3 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- GE Medical Systems: 2 (https://510kreport.com/company/ge-medical-systems)
- Shenzhen Biocare Electronics Co., Ltd.: 2 (https://510kreport.com/company/shenzhen-biocare-electronics)
- Medison America, Inc.: 2 (https://510kreport.com/company/medison-america)

## Firms that cite its devices most
- Medisono, LLC: 6 (https://510kreport.com/company/medisono)
- Sonoscape Medical Corp.: 4 (https://510kreport.com/company/sonoscape-medical)
- Chang Gung Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/chang-gung-medical-technology)
- Chang Gung Medical Supplies & Equipment Corp.: 1 (https://510kreport.com/company/chang-gung-medical-supplies-equipment)
- Guangzhou Sonostar Technologies Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-sonostar-technologies)
- Chison Medical Imaging Co., Ltd.: 1 (https://510kreport.com/company/chison-medical-imaging)
- Advanced Instrumentations, Inc.: 1 (https://510kreport.com/company/advanced-instrumentations)
- Chang Gung Medical Technology Co., Ltd. Linkou Fac: 1 (https://510kreport.com/company/chang-gung-medical-technology-co-linkou-fac)

## Its most-cited devices
- K112602: S6 Diagnostic Ultrasound System (2011), cited by 5
- K132768: S8 Exp Portable Digital Color Doppler Ultrasound System (2013), cited by 5
- K132527: Digital Color Doppler Ultasound System (2013), cited by 4
- K131088: Portable Digital Color Doppler Ultrasound System (2013), cited by 3
- K042369: Sonoscape Ultrasound System Ssi-1000/Ssi-5000 (2004), cited by 3
- K092922: Ssi-8000/S8/S6 Digital Color Doppler Ultrasound System, 2P1 Phased Array Diagnostic Ultrasound Transducer (2010), cited by 3

## Recent decisions
- K150045: S30/S40 Digital Color Doppler Ultraound System (Apr 28, 2015)
- K142714: S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System (Jan 29, 2015)
- K142815: S22 Digital Color Doppler Ultrasound System (Jan 28, 2015)
- K142710: S9 Portable Digital Color Doppler Ultrasound System (Jan 5, 2015)
- K142474: S12 Digital Color Doppler Ultrasound System (Dec 19, 2014)
- K131262: Digital Electrocardiographs (Nov 14, 2013)
- K132527: Digital Color Doppler Ultasound System (Nov 14, 2013)
- K132768: S8 Exp Portable Digital Color Doppler Ultrasound System (Oct 4, 2013)

Source page: https://510kreport.com/company/sonoscape