Axial3D Insight— 510(k) K222745

Substantially Equivalent

Axial Medical Printing Limited

FDA 510(k) clearance K222745 for Axial3D Insight, Substantially Equivalent on 2023-07-03. Applicant: Axial Medical Printing Limited. Device class: 2.

Clearance details

Applicant: Axial Medical Printing Limited
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2022-09-12
Decision date: 2023-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Belfast, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

K260879 — 4DM2026-09-10
K261795 — Quicktome Software Suite2026-09-10
K251417 — ReVISION 22026-09-09
K260525 — NextMR Spine2026-09-04
K260811 — Heartvue.Proton2026-08-26

More clearances from Axial Medical Printing Limited

K250369 — Axial3D Insight2025-09-18
K231607 — Axial3D Cloud Segmentation Service2024-01-24
K232841 — Axial3D Insight2023-11-15
K221511 — Axial3D Cloud Segmentation Service2022-06-23

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