Axial3D Cloud Segmentation Service— 510(k) K221511

Substantially Equivalent

Axial Medical Printing Limited

FDA 510(k) clearance K221511 for Axial3D Cloud Segmentation Service, Substantially Equivalent on 2022-06-23. Applicant: Axial Medical Printing Limited.

Clearance details

Applicant: Axial Medical Printing Limited
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2022-05-24
Decision date: 2022-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Belfast, GB

Download summary PDF View on FDA.gov ↗

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.