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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 K250369
Device Name Axial3D Insight
Applicant
Axial Medical Printing Limited
Alexander House
17a Ormeau Ave.
Belfast,  GB BT2 8HD
Applicant Contact Flatley Joanne
Correspondent
CS Life Sciences, Ltd.
Suite 10, Dunswood House
1 Dunswood Rd., Cumbernauld
Glasgow,  GB G67 3EN
Correspondent Contact May Lee
Regulation Number892.2050
Classification Product Code
QIH  
Date Received02/10/2025
Decision Date 09/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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