510(k) Report

FDA applicant

Axial Medical Printing Limited

Belfast, GB5 decisions2022–20250 recalls

FDA records 5 decisions for Axial Medical Printing Limited (Belfast, GB) from 2022 to 2025: 5 510(k) clearances. Most are in product codes QIH (Automated Radiological Image Processing Software) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 220 days from receipt to decision, against 150 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 4 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 Axial Medical Printing Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2022: 12023: 22024: 12025: 1
2022high 2 (2023) · low 1 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Axial Medical Printing Limited by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Axial Medical Printing Limited’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • QIHAutomated Radiological Image Processing Software3decisions
  • LLZSystem, Image Processing, Radiological2decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 220 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 150 days; 2 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 4 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.

  • K221511Axial3D Cloud Segmentation ServiceAxial Medical Printing Limited · 20222cite it
  • K232841Axial3D InsightAxial Medical Printing Limited · 20231cites it
  • K222745Axial3D InsightAxial Medical Printing Limited · 20231cites it

What has FDA decided for it lately?

  • K250369Axial3D InsightAxial Medical Printing Limited · 2025
  • K231607Axial3D Cloud Segmentation ServiceAxial Medical Printing Limited · 2024
  • K232841Axial3D InsightAxial Medical Printing Limited · 2023
  • K222745Axial3D InsightAxial Medical Printing Limited · 2023
  • K221511Axial3D Cloud Segmentation ServiceAxial Medical Printing Limited · 2022

All 5 as Axial Medical Printing Limited →