510(k) Report

FDA applicant

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

Seoul, KR1 decision2015–20150 recalls

FDA records 1 decision for Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012) (Seoul, KR) in 2015: 1 510(k) clearance. All are in product code EHD (Unit, X-Ray, Extraoral With Timer). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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. (Digimed Corporation Until 31/12/2012)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012) by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EHDUnit, X-Ray, Extraoral With Timer1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K152859Portable X-ray System (Model: MINIX-V / MINIX-S)Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012) · 20152cite it

What has FDA decided for it lately?

  • K152859Portable X-ray System (Model: MINIX-V / MINIX-S)Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012) · 2015

The one decision as Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012) →

Other applicant names beginning “Digimed”

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

Digimed Co., Ltd. 6