Axial3D Insight— 510(k) K250369

Substantially Equivalent

Axial Medical Printing Limited

FDA 510(k) clearance K250369 for Axial3D Insight, Substantially Equivalent on 2025-09-18. Applicant: Axial Medical Printing Limited.

Clearance details

Applicant: Axial Medical Printing Limited
Product code: Code QIH
Advisory panel: Radiology
Date received: 2025-02-10
Decision date: 2025-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Belfast, GB

Download summary PDF View on FDA.gov ↗

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