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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
510(k) Number K221564
Device Name Brainomix 360 e-ASPECTS
Applicant
Brainomix Limited
Suite 11-14, Suffolk House, 263 Banbury Road
Oxford,  GB OX2 7HN
Applicant Contact Gwilym Owen
Correspondent
Brainomix Limited
Suite 11-14, Suffolk House, 263 Banbury Road
Oxford,  GB OX2 7HN
Correspondent Contact Gwilym Owen
Regulation Number892.2060
Classification Product Code
POK  
Date Received05/31/2022
Decision Date 02/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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