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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K242123
Device Name Brainomix 360 e-CTA
Applicant
Brainomix Limited
First Floor Seacourt Tower
West Way
Oxford,  GB OX2 0JJ
Applicant Contact Thais Sala
Correspondent
Brainomix Limited
First Floor Seacourt Tower
West Way
Oxford,  GB OX2 0JJ
Correspondent Contact Zsolt Szrnka
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
QIH  
Date Received07/19/2024
Decision Date 01/06/2025
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		 No
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