Axial3D Insight

FDA 510(k) K232841 · Axial Medical Printing Limited

Substantially Equivalent

510(k) numberK232841

Submission

Device name
Axial3D Insight
Applicant
Axial Medical Printing Limited
Belfast, GB
Received
September 14, 2023
Decision date
November 15, 2023
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QIH – Automated Radiological Image Processing Software
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.

Other 510(k)s with product code QIH

510(k)DeviceApplicantDecision
K261795Quicktome Software SuiteQIH · Traditional Omniscient Neurotechnology Pty, Ltd.09/10/2026SE
K2608794DMQIH · Traditional Invia, LLC09/10/2026SE
K251417ReVISION 2QIH · Traditional Argus Cognitive, Inc.09/09/2026SE
K260525NextMR SpineQIH · Traditional MRI2CT, Inc.09/04/2026SE
K260811Heartvue.ProtonQIH · Traditional Heartvue.ai, Inc.08/26/2026SE
K261595Ceevra Reveal 4QIH · Traditional Ceevra, Inc.08/25/2026SE
K262127DS Core CBCT AnatomyQIH · Traditional Dentsply Sirona08/21/2026SE
K260584BoneMRIQIH · Traditional Mriguidance B.V.08/21/2026SE
K261641Lower Limb AI (LLAI)QIH · Traditional AI Planning Logic, Inc.08/18/2026SE
K253794Prostate CoreQIH · Traditional Lucida Medical, Ltd.08/10/2026SE

More from Lucida Medical, Ltd.

510(k)DeviceDecision
K250369Axial3D InsightQIH · Traditional 09/18/2025SE
K231607Axial3D Cloud Segmentation ServiceLLZ · Special 01/24/2024SE
K222745Axial3D InsightQIH · Traditional 07/03/2023SE
K221511Axial3D Cloud Segmentation ServiceLLZ · Traditional 06/23/2022SE

Questions and answers

When was Axial3D Insight cleared by the FDA?

Axial3D Insight (K232841) received a 510(k) decision of Substantially Equivalent on November 15, 2023, 62 days after the submission was received.

What is the product code of K232841?

The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.