510(k) Report

FDA applicant

Wellhofer Dosimetrie

Bartlett, TN2 decisions2003–20030 recalls

FDA records 2 decisions for Wellhofer Dosimetrie (Bartlett, TN) in 2003: 2 510(k) clearances. All are in product code IYE (Accelerator, Linear, Medical). Its devices cite 2 predicates, 0 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 Wellhofer Dosimetrie’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wellhofer Dosimetrie since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Wellhofer Dosimetrie 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?

  • IYEAccelerator, Linear, Medical2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 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.

  • K031634Omnipro I'mrtWellhofer Dosimetrie · 20032cite it
  • K032594One Dimensional Water Phantom, WP 1DWellhofer Dosimetrie · 20031cites it

What has FDA decided for it lately?

  • K032594One Dimensional Water Phantom, WP 1DWellhofer Dosimetrie · 2003
  • K031634Omnipro I'mrtWellhofer Dosimetrie · 2003

All 2 as Wellhofer Dosimetrie →