# Shenzhen Wisonic Medical Technology Co., Ltd.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 7 (2018–2023): 7 510(k) clearances
- Product codes: IYN (7)
- 510(k) review time since 2016: median 190 days, against 85 for FDA's reviews in the same codes and years (2 of 7 faster)
- Predicates its devices cite: 10 (3 its own); citations of its devices by later devices: 3 (3 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
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 4 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- GE Medical Systems Ultrasound and Primary Care Diagnostics: 2 (https://510kreport.com/company/ge-medical-systems-ultrasound-and-primary-care-diagnostics)
- FUJIFILM Sonosite, Inc.: 1 (https://510kreport.com/company/fujifilm-sonosite)

## Its most-cited devices
- K163712: Clover 50/Clover60/Clover70 Diagnostic Ultrasound System (2018), cited by 1
- K211886: Clivia series Diagnostic Ultrasound System (2021), cited by 1
- K180461: Navi e/Navi s/Navi X Diagnostic Ultrasound System (2018), cited by 1

## Recent decisions
- K230066: Carnation series Diagnostic Ultrasound System (Sep 15, 2023)
- K211886: Clivia series Diagnostic Ultrasound System (Dec 2, 2021)
- K210154: Labat series Diagnostic Ultrasound System (Jul 30, 2021)
- K191347: Paragon XHD Diagnostic Ultrasound System (Feb 7, 2020)
- K182715: Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System (Nov 20, 2018)
- K180461: Navi e/Navi s/Navi X Diagnostic Ultrasound System (May 9, 2018)
- K163712: Clover 50/Clover60/Clover70 Diagnostic Ultrasound System (Jan 2, 2018)

Source page: https://510kreport.com/company/shenzhen-wisonic-medical-technology