510(k) Report

FDA applicant

Iba Dosimetry GmbH

Schwarzenbruck, DE3 decisions2009–20201 recall

FDA records 3 decisions for Iba Dosimetry GmbH (Schwarzenbruck, DE) from 2009 to 2020: 3 510(k) clearances. Most are in product codes LHN (System, Radiation Therapy, Charged-Particle…) and IYE (Accelerator, Linear, Medical). Its devices cite 3 predicates, 0 of them its own earlier devices. 1 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 Iba Dosimetry GmbH’s devices, and how often a recall has named them.

FDA decisions per year

2in 2020

2009: 12020: 2
2009high 2 (2020) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2009high 1 (2025) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Iba Dosimetry GmbH by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • LHNSystem, Radiation Therapy, Charged-Particle, Medical2decisions
  • IYEAccelerator, Linear, Medical1decision

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 1 time; 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.

  • K201798myQA iONIba Dosimetry GmbH · 20201cites it

What has FDA decided for it lately?

  • K201798myQA iONIba Dosimetry GmbH · 20201 recall
  • K191821Blue Phantom PTIba Dosimetry GmbH · 2020
  • K092018Omnipro InclineIba Dosimetry GmbH · 2009

All 3 as Iba Dosimetry GmbH →

What has been recalled?

1 recall linked to its devices; the latest:

  • K201798myQA iON; Article Number: MQ10-000;Apr 1, 2025Class II