# Ge Hualun Medical Systems Co., Ltd.

- Location (FDA's records): Beijing, CN
- FDA decisions: 12 (2015–2025): 12 510(k) clearances
- Product codes: KPR (7), OXO (4), OWB (1)
- 510(k) review time since 2016: median 30 days, against 76 for FDA's reviews in the same codes and years (7 of 9 faster)
- Predicates its devices cite: 14 (9 its own); citations of its devices by later devices: 9 (9 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- GE Medical Systems: 2 (https://510kreport.com/company/ge-medical-systems)
- General Electric Co.: 1 (https://510kreport.com/company/general-electric)
- Ge Healthcare Surgery GE Oec Medical Systems, Inc.: 1 (https://510kreport.com/company/ge-healthcare-surgery-ge-oec-medical-systems)
- Ge Hangwei Medical Systems Co., Ltd.: 1 (https://510kreport.com/company/ge-hangwei-medical-systems)

## Its most-cited devices
- K172869: Discovery XR656 HD (2017), cited by 3
- K231892: Definium Pace Select (2023), cited by 1
- K143270: Optima XR646 (2015), cited by 1
- K240828: OEC One ASD (2024), cited by 1
- K172700: OEC One (2017), cited by 1
- K182626: OEC One (2018), cited by 1

## Recent decisions
- K253269: OEC One CFD (Nov 26, 2025)
- K250788: Definium Tempo Select (Aug 28, 2025)
- K240828: OEC One ASD (Dec 27, 2024)
- K242678: Definium Pace Select ET (Oct 1, 2024)
- K231892: Definium Pace Select (Sep 12, 2023)
- K191699: Discovery XR656 HD with VolumeRad (Jul 24, 2019)
- K182626: OEC One (Nov 16, 2018)
- K173612: Optima XR646 HD (Dec 11, 2017)

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