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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 K240680
Device Name CDM Insights
Applicant
Oxford Brain Diagnostics, Ltd.
Oxford Centre For Innovation, New Rd.
Oxford,  GB ox1 1by
Applicant Contact Terry Pollard
Correspondent
Ken Blocking Consulting, LLC
3400 N Central Expy.
Suite 110-225
Richardson,  TX  75080
Correspondent Contact Yulia Nikova
Regulation Number892.2050
Classification Product Code
QIH  
Date Received03/11/2024
Decision Date 12/06/2024
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		 No
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