# DRGEM Corporation

- Location (FDA's records): Gwangmyeong-Si, KR
- FDA decisions: 14 (2010–2026): 14 510(k) clearances
- Product codes: KPR (7), IZL (6), LLZ (1)
- 510(k) review time since 2016: median 61 days, against 43 for FDA's reviews in the same codes and years (7 of 13 faster)
- Predicates its devices cite: 14 (10 its own); citations of its devices by later devices: 17 (10 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
- Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.: 1 (https://510kreport.com/company/compania-mexicana-de-radiologia-cgr)
- Samsung Electronics Co., Ltd.: 1 (https://510kreport.com/company/samsung-electronics)
- Sedecal., Sa.: 1 (https://510kreport.com/company/sedecal)
- Oehm Und Rehbein GmbH: 1 (https://510kreport.com/company/oehm-und-rehbein)

## Firms that cite its devices most
- Samsung Electronics Co., Ltd.: 1 (https://510kreport.com/company/samsung-electronics)
- Medien International Co, Ltd.: 1 (https://510kreport.com/company/medien-international)
- Nanoray Biotech Co., Ltd.: 1 (https://510kreport.com/company/nanoray-biotech)
- Gemss Healthcare CO., LTD.: 1 (https://510kreport.com/company/gemss-healthcare)
- DRTECH Corporation: 1 (https://510kreport.com/company/drtech)
- Dk Medical System: 1 (https://510kreport.com/company/dk-medical-system)
- Jpi Healthcare Co, Ltd.: 1 (https://510kreport.com/company/jpi-healthcare)

## Its most-cited devices
- K102408: Digital Diagnostic X-Ray System (2010), cited by 4
- K202572: GXR-Series Diagnostic X-Ray System (2020), cited by 4
- K192364: GXR-Series Diagnostic X-Ray System (2019), cited by 3
- K242015: TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) (2024), cited by 2
- K183292: Topaz Mobile DR System (2019), cited by 1
- K202156: Diamond-5A/6A/8A (2020), cited by 1

## Recent decisions
- K260085: RAYMO Mobile X-ray System (Model: RAYMO) (May 14, 2026)
- K251443: PROMO (Aug 22, 2025)
- K242019: GXR-Series Diagnostic X-Ray System (Jan 7, 2025)
- K242015: TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) (Dec 16, 2024)
- K232178: GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) (Sep 19, 2023)
- K202572: GXR-Series Diagnostic X-Ray System (Sep 24, 2020)
- K202156: Diamond-5A/6A/8A (Sep 10, 2020)
- K201124: TOPAZ Mobile DR System (May 19, 2020)

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