510(k) Report

FDA applicant

Mrc Systems GmbH

Heidelberg, DE3 decisions2001–20032 recalls

FDA records 3 decisions for Mrc Systems GmbH (Heidelberg, DE) from 2001 to 2003: 3 510(k) clearances. Most are in product codes IXI (Block, Beam-Shaping, Radiation Therapy) and MUJ (System, Planning, Radiation Therapy Treatment). Its devices cite 3 predicates, 1 of them its own earlier devices. 2 recalls are 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 Mrc Systems GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mrc Systems GmbH since 2007.

Recalls per year

1in 2012

2009: 12012: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

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

See the 510(k) Report

Which product codes does it file in?

  • IXIBlock, Beam-Shaping, Radiation Therapy2decisions
  • MUJSystem, Planning, Radiation Therapy Treatment1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K022307Konrad, Model V.2.0Mrc Systems GmbH · 20021cites it
  • K030609ModuleafMrc Systems GmbH · 20031cites it
  • K011816Mini Multileaf Collimator, Model KmiMrc Systems GmbH · 20011cites it

What has FDA decided for it lately?

  • K030609ModuleafMrc Systems GmbH · 20031 recall
  • K022307Konrad, Model V.2.0Mrc Systems GmbH · 20021 recall
  • K011816Mini Multileaf Collimator, Model KmiMrc Systems GmbH · 2001

All 3 as Mrc Systems GmbH →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K030609Siemens mMLC (ModuLeaf) safety bar and trolley label. Siemens Medical Solutions USA…Feb 7, 2012
  • K022307Coherence Dosimetrist, version 2.2. Intended use: Medical charged-particle radiation…Nov 6, 2009