510(k) Report

FDA applicant

Ptw-Freiburg Physikalisch-Technische-Werkstaetten

Freiburg, DE3 decisions2017–20224 recalls

FDA records 3 decisions for Ptw-Freiburg Physikalisch-Technische-Werkstaetten (Freiburg, DE) from 2017 to 2022: 3 510(k) clearances. All are in product code IYE (Accelerator, Linear, Medical). Since 2016 its 510(k)s took a median of 246 days from receipt to decision, against 94 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 of them its own earlier devices. 4 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 Ptw-Freiburg Physikalisch-Technische-Werkstaetten’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2017: 12020: 12022: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2026

2021: 12023: 12024: 12026 (partial year): 1
2017high 1 (2021) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Ptw-Freiburg Physikalisch-Technische-Werkstaetten by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IYEAccelerator, Linear, Medical3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 246 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 94 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 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.

  • K191646Beamscan MRPtw-Freiburg Physikalisch-Technische-Werkstaetten · 20201cites it

What has FDA decided for it lately?

  • K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten · 20222 recalls
  • K191646Beamscan MRPtw-Freiburg Physikalisch-Technische-Werkstaetten · 2020
  • K160405Octavius I, Octavius II, Octavius Iii, Octavius 4DPtw-Freiburg Physikalisch-Technische-Werkstaetten · 20172 recalls

All 3 as Ptw-Freiburg Physikalisch-Technische-Werkstaetten →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K213370Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number…Aug 4, 2026Class II
  • K213370Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation…Feb 8, 2024Class II
  • K160405BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a…Jun 7, 2023Class II
  • K160405Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0…Aug 27, 2021Class II