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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K231607
Device Name Axial3D Cloud Segmentation Service
Applicant
Axial Medical Printing Limited
17a Ormeau Ave.
Belfast,  GB BT2 8HD
Applicant Contact Jenna McGarry
Correspondent
Maxis Medical, LLC
3031 Tisch Way
Suite 1010
San Jose,  CA  95128
Correspondent Contact Sujith Shetty
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/01/2023
Decision Date 01/24/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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