# Ge Hangwei Medical Systems Co., Ltd.

- Location (FDA's records): Beijing, CN
- FDA decisions: 10 (2011–2024): 10 510(k) clearances
- Product codes: JAK (5), LNH (3), OXO (1), MOS (1)
- 510(k) review time since 2016: median 87 days, against 112 for FDA's reviews in the same codes and years (4 of 5 faster)
- Predicates its devices cite: 11 (3 its own); citations of its devices by later devices: 8 (3 its own)
- Recalls linked to its devices: 19 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- GE Medical Systems: 4 (https://510kreport.com/company/ge-medical-systems)
- Ge Healthcare Japan Corporation: 2 (https://510kreport.com/company/ge-healthcare-japan)
- Ge Dec Medical Systems: 1 (https://510kreport.com/company/ge-dec-medical-systems)
- Mri Devices Corp.: 1 (https://510kreport.com/company/mri-devices)

## Firms that cite its devices most
- Shenzhen RF Tech Co., Ltd.: 2 (https://510kreport.com/company/shenzhen-rf-tech)
- Ge Healthcare Japan Corporation: 1 (https://510kreport.com/company/ge-healthcare-japan)
- Ge Hualun Medical Systems Co., Ltd.: 1 (https://510kreport.com/company/ge-hualun-medical-systems)
- Ge Healthcare (Ge Medical Systems, LLC): 1 (https://510kreport.com/company/ge-healthcare-ge-medical-systems)

## Its most-cited devices
- K123417: Brivo MR355, Optima MR360 (2013), cited by 2
- K103330: Brivo MR355, Optima MR360 (2011), cited by 2
- K192686: Revolution Maxima, Revolution Ace (2019), cited by 1
- K160131: OEC Elite MiniView (2016), cited by 1
- K122694: GE 8CH Foot Ankle Coil (2012), cited by 1
- K123596: Optima CT520 (2013), cited by 1

## Recent decisions
- K233749: Revolution Ascend Sliding (Feb 22, 2024)
- K192956: Auto Positioning (Jan 16, 2020)
- K192686: Revolution Maxima, Revolution Ace (Oct 24, 2019)
- K171013: Revolution ACT (Jun 5, 2017)
- K160131: OEC Elite MiniView (Jun 21, 2016)
- K123596: Optima CT520 (Feb 8, 2013)
- K123417: Brivo MR355, Optima MR360 (Jan 17, 2013)
- K122694: GE 8CH Foot Ankle Coil (Oct 25, 2012)

Source page: https://510kreport.com/company/ge-hangwei-medical-systems