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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K242411
Device Name Brainomix 360 e-Lung
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 Number892.1750
Classification Product Code
JAK  
Date Received08/14/2024
Decision Date 02/19/2025
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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