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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K232569
Device Name CAREMIBRAIN
Applicant
General Equipment For Medical Imaging, S.A.
(Oncovision Gem-Imaging S.A.)
Calle De Jeroni De Montsoriu, 92-Bj Iz
Valencia,  ES 46022
Applicant Contact Maria Climent
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number892.1200
Classification Product Code
KPS  
Date Received08/24/2023
Decision Date 09/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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