510(k) Report

FDA applicant

ROPCA ApS

Odense M, DK2 decisions2026–20260 recalls

FDA records 2 decisions for ROPCA ApS (Odense M, DK) in 2026: 2 510(k) clearances. Most are in product codes QIH (Automated Radiological Image Processing Software) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 3 predicates, 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 ROPCA ApS’s devices, and how often a recall has named them.

FDA decisions per year

2in 2026

2026 (partial year): 2
2026high 2 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

FIG. 1 — ROPCA ApS by year, 2026–2026Sources: 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 Software1decision
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

All 2 as ROPCA ApS →