510(k) Report

FDA applicant

Oehm Und Rehbein GmbH

Rockstock, DE5 decisions2007–20180 recalls

FDA records 5 decisions for Oehm Und Rehbein GmbH (Rockstock, DE) from 2007 to 2018: 5 510(k) clearances. Most are in product codes MQB (Solid State X-Ray Imager (Flat Panel/Digital…) and LLZ (System, Image Processing, Radiological). Its devices cite 6 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 Oehm Und Rehbein GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2007: 12009: 12013: 12014: 12018: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Oehm Und Rehbein GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)2decisions
  • LLZSystem, Image Processing, Radiological2decisions
  • IZLSystem, X-Ray, Mobile1decision

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 2 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.

  • K091364Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Oehm Und Rehbein GmbH · 20095cite it
  • K070618Dicompacs, Model 5Oehm Und Rehbein GmbH · 20075cite it
  • K182317AMADEO M-DR mini, AMADEO M-AX miniOehm Und Rehbein GmbH · 20183cite it
  • K141440Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH · 20141cites it
  • K131211Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH · 20131cites it

What has FDA decided for it lately?

  • K182317AMADEO M-DR mini, AMADEO M-AX miniOehm Und Rehbein GmbH · 2018
  • K141440Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH · 2014
  • K131211Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH · 2013
  • K091364Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Oehm Und Rehbein GmbH · 2009
  • K070618Dicompacs, Model 5Oehm Und Rehbein GmbH · 2007

All 5 as Oehm Und Rehbein GmbH →