510(k) Report

FDA applicant

Medicad Hectec GmbH

Altdorf, DE2 decisions2018–20190 recalls

FDA records 2 decisions for Medicad Hectec GmbH (Altdorf, DE) from 2018 to 2019: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). 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 Medicad Hectec GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2018: 12019: 1
2018high 1 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Medicad Hectec GmbH by year, 2018–2026Sources: 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, Radiological2decisions

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K170702mediCAD 4.0Medicad Hectec GmbH · 20181cites it

What has FDA decided for it lately?

  • K183412mediCAD WebMedicad Hectec GmbH · 2019
  • K170702mediCAD 4.0Medicad Hectec GmbH · 2018

All 2 as Medicad Hectec GmbH →