Axial3D Cloud Segmentation Service— 510(k) K231607

Name: FDA 510(k) clearance K231607
Creator: U.S. Food and Drug Administration
Published: 2024-01-24

Substantially Equivalent

Axial Medical Printing Limited

FDA 510(k) clearance K231607 for Axial3D Cloud Segmentation Service, Substantially Equivalent on 2024-01-24. Applicant: Axial Medical Printing Limited. Device class: 2.

Clearance details

Applicant: Axial Medical Printing Limited
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2023-06-01
Decision date: 2024-01-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Belfast, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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More clearances from Axial Medical Printing Limited

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K250369 — Axial3D Insight2025-09-18
K232841 — Axial3D Insight2023-11-15
K222745 — Axial3D Insight2023-07-03
K221511 — Axial3D Cloud Segmentation Service2022-06-23

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.