510(k) Report

FDA applicant

Digimed Co., Ltd.

Seoul, KR6 decisions2008–20231 recall

FDA records 6 decisions for Digimed Co., Ltd. (Seoul, KR) from 2008 to 2023: 6 510(k) clearances. All are in product code EHD (Unit, X-Ray, Extraoral With Timer). Since 2016 its 510(k)s took a median of 123 days from receipt to decision, against 58 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Digimed Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Digimed Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2008: 12011: 12018: 12022: 22023: 1
2008high 2 (2022) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2008high 1 (2025) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Digimed Co., Ltd. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Digimed Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • EHDUnit, X-Ray, Extraoral With Timer6decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 123 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 58 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K082167Portable X-Ray System, Models Diox-602, ProxDigimed Corporation · 20083cite it
  • K103600Portable X-Ray SystemDigimed Corporation · 20111cites it

What has FDA decided for it lately?

  • K221587DHX-70H, XTG-70HDigimed Co., Ltd. · 2023
  • K220579Hybrid C70Digimed Co., Ltd. · 2022
  • K220574Hybrid S70Digimed Co., Ltd. · 2022
  • K181891Portable X-ray System (Model: MiniX-V, Mini X-S)Digimed Co., Ltd. · 2018
  • K103600Portable X-Ray SystemDigimed Corporation · 2011
  • K082167Portable X-Ray System, Models Diox-602, ProxDigimed Corporation · 20081 recall

All 4 as Digimed Co., Ltd. →All 2 as Digimed Corporation →

What has been recalled?

1 recall linked to its devices; the latest:

  • K082167Portable X-ray systemJun 19, 2025Class II

Other applicant names beginning “Digimed”

FDA records each applicant name separately; these may or may not be the same firm.

Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012) 1