510(k) Report

FDA applicant

Cercare Medical A/S

Aarhus C, DK4 decisions2023–20260 recalls

FDA records 4 decisions for Cercare Medical A/S (Aarhus C, DK) from 2023 to 2026: 4 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 160 days from receipt to decision, against 131 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 2 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 Cercare Medical A/S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2023: 12024: 12026 (partial year): 2
2023high 2 (2026) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Cercare Medical A/S by year, 2023–2026Sources: 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, Radiological3decisions
  • QIHAutomated Radiological Image Processing Software1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 160 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 131 days; 0 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 2 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.

  • K230016Cercare Medical NeurosuiteCercare Medical A/S · 20231cites it
  • K241989Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertCercare Medical A/S · 20241cites it

What has FDA decided for it lately?

  • K260316CMN Capillary Function with Oncology Virtual ExpertCercare Medical A/S · 2026
  • K253831CMN Capillary Function with Virtual Expert for MRI, CT and CBCTCercare Medical A/S · 2026
  • K241989Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertCercare Medical A/S · 2024
  • K230016Cercare Medical NeurosuiteCercare Medical A/S · 2023

All 4 as Cercare Medical A/S →

Other applicant names beginning “Cercare”

FDA records each applicant name separately; these may or may not be the same firm.

Cercare Medical Aps 1