510(k) Report

FDA applicant

Hi-D Imaging AG

Winterthur, CH2 decisions2025–20260 recalls

FDA records 2 decisions for Hi-D Imaging AG (Winterthur, CH) from 2025 to 2026: 2 510(k) clearances. All are in product code QIH (Automated Radiological Image Processing Software). Its devices cite 2 predicates, 1 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 Hi-D Imaging AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025: 12026 (partial year): 1
2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Hi-D Imaging AG by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QIHAutomated Radiological Image Processing Software2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K241984Hi-D Imaging 4TAVRHi-D Imaging AG · 20251cites it

What has FDA decided for it lately?

  • K261535Hi-D Imaging 4TAVRHi-D Imaging AG · 2026
  • K241984Hi-D Imaging 4TAVRHi-D Imaging AG · 2025

All 2 as Hi-D Imaging AG →