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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 K232841
Device Name Axial3D Insight
Applicant
Axial Medical Printing Limited
17A Ormeau Avenue
Belfast,  GB BT2 8HD
Applicant Contact Joanne Flatley
Correspondent
Maxis Medical LLC
3031 Tisch Way, Suite 1010
San Jose,  CA  95128
Correspondent Contact Sujith Shetty
Regulation Number892.2050
Classification Product Code
QIH  
Date Received09/14/2023
Decision Date 11/15/2023
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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