FDA applicant

Scanditronix Wellhofer GmbH

Schwarzenbruck, DE1 decision2007–20073 recalls

FDA records 1 decision for Scanditronix Wellhofer GmbH (Schwarzenbruck, DE) in 2007: 1 510(k) clearance. All are in product code IYE (Accelerator, Linear, Medical). Its devices cite 3 predicates, 0 of them its own earlier devices. 3 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 Scanditronix Wellhofer GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2015

2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Scanditronix Wellhofer 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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Other applicant names beginning “Scanditronix”

FDA records each applicant name separately; these may or may not be the same firm.

Scanditronix, Inc. 7 Scanditronix Medical AB 4 Scanditronix Wellhofer North America 1

Scanditronix Wellhofer GmbH

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Scanditronix”