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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 Rd.
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 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
Predetermined Change
Control Plan Authorized		 No
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