510(k) Report

FDA applicant

Sohard AG

Fuerth, Bayern, DE1 decision2005–20050 recalls

FDA records 1 decision for Sohard AG (Fuerth, Bayern, DE) in 2005: 1 510(k) clearance. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 1 predicate, 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 Sohard AG’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sohard AG since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sohard AG’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K043483Radin, Model V 3.0Sohard AG · 2005

The one decision as Sohard AG →