510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Digimed Co., Ltd

Seoul, KR

DIGIMED CO., LTD appears in FDA device records in Seoul, KR. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
6
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 6 510(k) clearances for Digimed Co., Ltd between 2008 and 2023. The busiest year on record is 2022, with 2. The most recent is 2023, with 1.

Clearances by year, as a table
510(k) clearance decisions for Digimed Co., Ltd, by decision year
YearClearances
20081
20111
20181
20222
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K221587DHX-70H, XTG-70HEHDSubstantially Equivalent
K220579Hybrid C70EHDSubstantially Equivalent
K220574HYBRID S70EHDSubstantially Equivalent
K181891Portable X-ray System (Model: MiniX-V, Mini X-S)EHDSubstantially Equivalent
K103600PORTABLE X-RAY SYSTEMEHDSubstantially Equivalent
K082167PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROXEHDSubstantially Equivalent

Registered establishments

FDA registered establishments for Digimed Co., Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30079332323007933232DIGIMED CO., LTD401, 402, 406~411-ho, A-dong, Seoul 08505 KR2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2117-2025Portable X-ray systemSome DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.Class IIOpen, Classified

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Digimed Co., Ltd edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain