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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 K223555
Device Name Brainomix 360 e-CTP
Applicant
Brainomix Limited
First Floor, Seacourt Tower
West Way
Oxford,  GB OX2 7HN
Applicant Contact Gwilym Owen
Correspondent
Brainomix Limited
Suite 11-14, Suffolk House
263 Banbury Rd.
Oxford,  GB OX2 7HN
Correspondent Contact Thais Sala
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/28/2022
Decision Date 06/01/2023
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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