510(k) Report

FDA applicant

DRGEM Corporation

Gwangmyeong-Si, KR14 decisions2010–20260 recalls

FDA records 14 decisions for DRGEM Corporation (Gwangmyeong-Si, KR) from 2010 to 2026: 14 510(k) clearances. Most are in product codes KPR (System, X-Ray, Stationary) and IZL (System, X-Ray, Mobile). Since 2016 its 510(k)s took a median of 61 days from receipt to decision, against 43 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 10 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, radiology panel, where it files most

How often FDA has decided DRGEM Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2010: 12019: 52020: 32023: 12024: 12025: 22026 (partial year): 1
2010high 5 (2019) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — DRGEM Corporation by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KPRSystem, X-Ray, Stationary7decisions
  • IZLSystem, X-Ray, Mobile6decisions
  • LLZSystem, Image Processing, Radiological1decision

How long do its 510(k) reviews take?

Since 2016, its 13 510(k)s took a median of 61 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 43 days; 7 of its 13 were faster than that.

Whose devices does it build on?

Its devices cite 14 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 17 times; 10 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.

  • K102408Digital Diagnostic X-Ray SystemDRGEM Corporation · 20104cite it
  • K202572GXR-Series Diagnostic X-Ray SystemDRGEM Corporation · 20204cite it
  • K192364GXR-Series Diagnostic X-Ray SystemDRGEM Corporation · 20193cite it
  • K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)DRGEM Corporation · 20242cite it
  • K183292Topaz Mobile DR SystemDRGEM Corporation · 20191cites it
  • K202156Diamond-5A/6A/8ADRGEM Corporation · 20201cites it

What has FDA decided for it lately?

  • K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM Corporation · 2026
  • K251443PROMODRGEM Corporation · 2025
  • K242019GXR-Series Diagnostic X-Ray SystemDRGEM Corporation · 2025
  • K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)DRGEM Corporation · 2024
  • K232178GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)DRGEM Corporation · 2023
  • K202572GXR-Series Diagnostic X-Ray SystemDRGEM Corporation · 2020
  • K202156Diamond-5A/6A/8ADRGEM Corporation · 2020
  • K201124TOPAZ Mobile DR SystemDRGEM Corporation · 2020

All 14 as DRGEM Corporation →