Axial3D Cloud Segmentation Service

FDA 510(k) K231607 · Axial Medical Printing Limited

Substantially Equivalent

510(k) numberK231607

Submission

Device name
Axial3D Cloud Segmentation Service
Applicant
Axial Medical Printing Limited
Belfast, GB
Received
June 1, 2023
Decision date
January 24, 2024
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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More from Avara Software

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K250369Axial3D InsightQIH · Traditional 09/18/2025SE
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K222745Axial3D InsightQIH · Traditional 07/03/2023SE
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Questions and answers

When was Axial3D Cloud Segmentation Service cleared by the FDA?

Axial3D Cloud Segmentation Service (K231607) received a 510(k) decision of Substantially Equivalent on January 24, 2024, 237 days after the submission was received.

What is the product code of K231607?

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