510(k) Report

FDA applicant

Apelem-Dms Group

Nimes 30005, FR3 decisions2013–20210 recalls

FDA records 3 decisions for Apelem-Dms Group (Nimes 30005, FR) from 2013 to 2021: 3 510(k) clearances. All are in product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified). Its devices cite 3 predicates, 2 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 Apelem-Dms Group’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2013: 12016: 12021: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Apelem-Dms Group by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JAASystem, X-Ray, Fluoroscopic, Image-Intensified3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K160301Platinum dRF Imaging SystemApelem-Dms Group · 20161cites it
  • K131766Platinum DRF Imaging SystemApelem-Dms Group · 20131cites it

What has FDA decided for it lately?

  • K203010Platinum dRF Imaging SystemApelem-Dms Group · 2021
  • K160301Platinum dRF Imaging SystemApelem-Dms Group · 2016
  • K131766Platinum DRF Imaging SystemApelem-Dms Group · 2013

All 3 as Apelem-Dms Group →