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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer-Assisted Triage And Notification Software
510(k) Number K231195
Device Name Brainomix 360 Triage ICH
Applicant
Brainomix Limited
First Floor Seacourt Tower
West Way
Oxford,  GB OX2 0JJ
Applicant Contact Szrnka Zsolt
Correspondent
Brainomix Limited
First Floor Seacourt Tower
West Way
Oxford,  GB OX2 0JJ
Correspondent Contact Szrnka Zsolt
Regulation Number892.2080
Classification Product Code
QAS  
Date Received04/27/2023
Decision Date 07/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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