# Digimed Co., Ltd.

- Location (FDA's records): Seoul, KR
- FDA decisions: 6 (2008–2023): 6 510(k) clearances
- Names in FDA's records: Digimed Co., Ltd. (4); Digimed Corporation (2)
- Product codes: EHD (6)
- 510(k) review time since 2016: median 123 days, against 58 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 4 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Meta Biomed Co., Ltd.: 3 (https://510kreport.com/company/meta-biomed)
- Genoray Co., Ltd.: 2 (https://510kreport.com/company/genoray)
- Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012): 1 (https://510kreport.com/company/digimed-co-digimed-until-31-12-2012)

## Firms that cite its devices most
- Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012): 2 (https://510kreport.com/company/digimed-co-digimed-until-31-12-2012)
- Hanjin Digi-X Co., Ltd.: 1 (https://510kreport.com/company/hanjin-digi-x)
- Meta Biomed Co., Ltd.: 1 (https://510kreport.com/company/meta-biomed)

## Its most-cited devices
- K082167: Portable X-Ray System, Models Diox-602, Prox (2008), cited by 3
- K103600: Portable X-Ray System (2011), cited by 1

## Recent decisions
- K221587: DHX-70H, XTG-70H (Mar 3, 2023)
- K220579: Hybrid C70 (Sep 1, 2022)
- K220574: Hybrid S70 (Apr 22, 2022)
- K181891: Portable X-ray System (Model: MiniX-V, Mini X-S) (Aug 10, 2018)
- K103600: Portable X-Ray System (Apr 8, 2011)
- K082167: Portable X-Ray System, Models Diox-602, Prox (Sep 26, 2008)

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