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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name automated radiological image processing software
510(k) Number K222745
Device Name Axial3D Insight
Axial Medical Printing Limited
17A Ormeau Avenue
Belfast,  GB BT2 8HD
Applicant Contact Jenna McGarry
Maxis Medical LLC
7052 Hollow Lake Way
San Jose,  CA  95120
Correspondent Contact Sujith Shetty
Regulation Number892.2050
Classification Product Code
Date Received09/12/2022
Decision Date 07/03/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No