FDA applicant

Scanditronix Wellhofer North America

Bartlett, TN1 decision2000–20000 recalls

FDA records 1 decision for Scanditronix Wellhofer North America (Bartlett, TN) in 2000: 1 510(k) clearance. All are in product code IYE (Accelerator, Linear, Medical). 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 Scanditronix Wellhofer North America’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Scanditronix Wellhofer North America since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Scanditronix Wellhofer North America’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 GmbH 1

Scanditronix Wellhofer North America

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Scanditronix”