510(k) Report

FDA applicant

Medicalcommunications GmbH

Heidelberg, DE1 decision2020–20201 recall

FDA records 1 decision for Medicalcommunications GmbH (Heidelberg, DE) in 2020: 1 510(k) clearance. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Medicalcommunications GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2020high 1 (2025) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — Medicalcommunications GmbH by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological1decision

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K200132AshvinsMedicalcommunications GmbH · 20201 recall

The one decision as Medicalcommunications GmbH →

What has been recalled?

1 recall linked to its devices; the latest:

  • K200132Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to…Sep 9, 2025Class II