# Genoray Co., Ltd.

- Location (FDA's records): Seongnam-Si, KR
- FDA decisions: 24 (2007–2026): 24 510(k) clearances
- Product codes: MUH (7), OWB (7), OAS (4), EHD (3), LLZ (2), MUE (1)
- 510(k) review time since 2016: median 170 days, against 105 for FDA's reviews in the same codes and years (4 of 13 faster)
- Predicates its devices cite: 31 (11 its own); citations of its devices by later devices: 22 (11 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
- VATECH Co., Ltd.: 2 (https://510kreport.com/company/vatech)
- Ge Oec Medical Systems, Inc.: 1 (https://510kreport.com/company/ge-oec-medical-systems)
- Philips Medical Systems, Inc.: 1 (https://510kreport.com/company/philips-medical-systems)
- Instrumentarium Dental, Inc.: 1 (https://510kreport.com/company/instrumentarium-dental)
- Instrumentarium Corp. Imaging Division: 1 (https://510kreport.com/company/instrumentarium-imaging-division)
- Meta Biomed Co., Ltd.: 1 (https://510kreport.com/company/meta-biomed)
- Schick Technologies, Inc.: 1 (https://510kreport.com/company/schick-technologies)
- Edlen Imaging, LLC: 1 (https://510kreport.com/company/edlen-imaging)

## Firms that cite its devices most
- Digimed Co., Ltd.: 2 (https://510kreport.com/company/digimed)
- Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012): 1 (https://510kreport.com/company/digimed-co-digimed-until-31-12-2012)
- Sirona Dental Systems GmbH: 1 (https://510kreport.com/company/sirona-dental-systems)
- Edlen Imaging, LLC: 1 (https://510kreport.com/company/edlen-imaging)
- Hanjin Digi-X Co., Ltd.: 1 (https://510kreport.com/company/hanjin-digi-x)
- Exaro Co., Ltd.: 1 (https://510kreport.com/company/exaro)
- Iray Technology Taicang, Ltd.: 1 (https://510kreport.com/company/iray-technology-taicang)
- Gemss Healthcare CO., LTD.: 1 (https://510kreport.com/company/gemss-healthcare)

## Its most-cited devices
- K063121: Portable X-Ray System, Model Port-X II (2007), cited by 7
- K091918: Zen-2090 Pro, Fluoroscopic X-Ray System, Model Zen-2090 Pro (2009), cited by 3
- K150354: PAPAYA 3D Plus (2015), cited by 3
- K141700: Papaya Plus, Digital Extraoral Source X-Ray System (2014), cited by 2
- K120263: Volux 21C, Digital Extraoral Source X-Ray System (2012), cited by 1
- K172810: Port-X IV (2018), cited by 1

## Recent decisions
- K252229: Belliger Ace (Apr 2, 2026)
- K250060: GT300; GT300-C (Oct 8, 2025)
- K243420: Hestia (Jul 17, 2025)
- K232085: Dvas (Dvas-M, Dvas-W) (Dec 8, 2023)
- K232158: GenX-CR (Sep 13, 2023)
- K230787: Oscar 15 & Oscar 15i (Jul 20, 2023)
- K220423: PAPAYA & PAPAYA Plus (May 19, 2022)
- K220392: PAPAYA 3D & PAPAYA 3D Plus (May 19, 2022)

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