510(k) · Radiology

Axial3D Insight

by Axial Medical Printing Limited

Axial3D Insight is an AI-enabled medical device from Axial Medical Printing Limited that the U.S. FDA cleared through 510(k) K250369 on September 18, 2025. Its lead review panel is Radiology and its primary product code is QIH (Automated Radiological Image Processing Software).

See also FDA-cleared AI radiology devices in 2025, all FDA AI clearances in 2025, top radiology AI devices.

Key facts

Submission numberK250369
Pathway510(k)
Date of final decision
Company (FDA list)Axial Medical Printing Limited
Lead review panelRadiology
Primary product codeQIH — Automated Radiological Image Processing Software
Applicant (openFDA)Axial Medical Printing Limited
Applicant locationBelfast, GB
Device classClass 2
Regulation number21 CFR 892.2050
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Axial3D Insight went through this pathway (K250369).

openFDA lists it as a Class 2 device under 21 CFR 892.2050. Class II devices are moderate risk and are subject to general and special controls.

Product code QIH covers 305 devices on the FDA AI list. By decision date, this device is #231 of 305 under that code. Axial Medical Printing Limited has 3 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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