Axial3D Cloud Segmentation Service

FDA 510(k) K221511 · Axial Medical Printing Limited

Substantially Equivalent

510(k) numberK221511

Submission

Device name
Axial3D Cloud Segmentation Service
Applicant
Axial Medical Printing Limited
Belfast, GB
Received
May 24, 2022
Decision date
June 23, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

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

510(k)DeviceDecision
K250369Axial3D InsightQIH · Traditional 09/18/2025SE
K231607Axial3D Cloud Segmentation ServiceLLZ · Special 01/24/2024SE
K232841Axial3D InsightQIH · Special 11/15/2023SE
K222745Axial3D InsightQIH · Traditional 07/03/2023SE

Questions and answers

When was Axial3D Cloud Segmentation Service cleared by the FDA?

Axial3D Cloud Segmentation Service (K221511) received a 510(k) decision of Substantially Equivalent on June 23, 2022, 30 days after the submission was received.

What is the product code of K221511?

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