510(k) Report

FDA applicant

Medphoton GmbH

Salzburg, AT4 decisions2016–20250 recalls

FDA records 4 decisions for Medphoton GmbH (Salzburg, AT) from 2016 to 2025: 4 510(k) clearances. Most are in product codes OWB (Interventional Fluoroscopic X-Ray System) and IYE (Accelerator, Linear, Medical). Since 2016 its 510(k)s took a median of 143 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 5 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 Medphoton GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2016: 12019: 12020: 12025: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Medphoton GmbH by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medphoton 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?

  • OWBInterventional Fluoroscopic X-Ray System2decisions
  • IYEAccelerator, Linear, Medical2decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 143 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 5 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.

  • K161400ImagingRing SystemMedphoton GmbH · 20161cites it
  • K203281Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-XMedphoton GmbH · 20201cites it

What has FDA decided for it lately?

  • K234067ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)Medphoton GmbH · 2025
  • K203281Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-XMedphoton GmbH · 2020
  • K191267ImagingRing System on RailsMedphoton GmbH · 2019
  • K161400ImagingRing SystemMedphoton GmbH · 2016

All 4 as Medphoton GmbH →