# Gemss Medical Systems Co., Ltd.

- Location (FDA's records): Seongnam-Si, KR
- FDA decisions: 4 (2014–2017): 4 510(k) clearances
- Product codes: OXO (1), OWB (1), JAA (1), KPR (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 0 (0 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
- United Radiology Systems, Inc.: 3 (https://510kreport.com/company/united-radiology-systems)
- Eastman Kodak Company: 1 (https://510kreport.com/company/eastman-kodak)

## Recent decisions
- K163140: SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System (May 26, 2017)
- K160065: GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System (May 20, 2016)
- K133695: TITAN 11 (Aug 7, 2014)
- K132289: Gemss Medical Systems Surgical Mobile Fluoroscopic X-Ray System (Jun 16, 2014)

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