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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 K221511
Device Name Axial3D Cloud Segmentation Service
Applicant
Axial Medical Printing Limited
17A Ormeau Avenue
Belfast,  GB BT2 8HD
Applicant Contact Jenna McGarry
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/24/2022
Decision Date 06/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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