Data / Medical devices / South Korea / Digimed Co., Ltd

Digimed Co., Ltd: FDA-registered device maker in Seoul, South Korea, 5 510(k) clearances

Name: Digimed Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Digimed Co., Ltd is registered with the FDA (registration 3007933232) in Seoul, South Korea. It lists 1 device type. The FDA files 5 510(k) clearances under its listings, the newest dated March 3, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007933232
Address: 401, 402, 406~411-ho, A-dong 101, Gasan digital 2-ro, Geumcheon-Gu, Seoul, South Korea, 08505
Owner or operator: DIGIMED (10034335)
Roles: Manufacturer
First device listed: November 24, 2010
Registered through: 2026
Brand names listed: DIOX-602, Dhx-70h, HYBRID Pro, HYBRID S70, Hybrid C70, MiniX-S, MiniX-V, PROX and more

Devices it lists

Device	Product code	Class	Role	Source
Unit, X-Ray, Extraoral With Timer	EHD	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 3, 2023	K221587	DHX-70H, XTG-70H	EHD	Substantially Equivalent	Digimed Co., Ltd.	accessdata.fda.gov
September 1, 2022	K220579	Hybrid C70	EHD	Substantially Equivalent	Digimed Co., Ltd.	accessdata.fda.gov
April 22, 2022	K220574	HYBRID S70	EHD	Substantially Equivalent	Digimed Co., Ltd.	accessdata.fda.gov
August 10, 2018	K181891	Portable X-ray System (Model: MiniX-V, Mini X-S)	EHD	Substantially Equivalent	Digimed Co., Ltd.	accessdata.fda.gov
September 26, 2008	K082167	PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX	EHD	Substantially Equivalent	Digimed Corporation	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 19, 2025	97270	Class II	Ongoing	Portable X-ray system	Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.	accessdata.fda.gov

Compare with other makers

All makers of Unit, X-Ray, Extraoral With Timer

Updated July 18, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.