510(k) Report

FDA applicant

F. Walter Hanel GmbH

North Attleboro, MA3 decisions1993–19961 recall

FDA records 3 decisions for F. Walter Hanel GmbH (North Attleboro, MA) from 1993 to 1996: 3 510(k) clearances. Most are in product codes JAA (System, X-Ray, Fluoroscopic, Image-Intensified) and KPY (Shield, Protective, Personnel). 1 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 F. Walter Hanel GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for F. Walter Hanel GmbH since 2007.

Recalls per year

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — F. Walter Hanel GmbH 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?

  • JAASystem, X-Ray, Fluoroscopic, Image-Intensified1decision
  • KPYShield, Protective, Personnel1decision
  • IWQCurtain, Protective, Radiographic1decision

What has FDA decided for it lately?

  • K954945Hanel Mavig Monitor Suspension SystemF. Walter Hanel GmbH · 1996
  • K945238Mavig Lower Body Protection Systems, Assembly Models 6265, 6266, 6267, 6268, 6269/0, 629/1, and 6269/2F. Walter Hanel GmbH · 1994
  • K934206Mavig Angio Shield Models 6290 & 6272F. Walter Hanel GmbH · 19931 recall

All 3 as F. Walter Hanel GmbH →

What has been recalled?

1 recall linked to its devices; the latest:

  • K934206Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS…Jun 28, 2018Class II