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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K232231
Device Name QP-Brain®
Applicant
Quibim S.L.
Avenida Aragón 30, 13th Floor, Office I-J
Valencia,  ES 46021
Applicant Contact Angel Alberich Bayarri
Correspondent
Hogan Lovells US LLP
555 13th St. NW
Washington,  DC  20005
Correspondent Contact John J Smith
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received07/27/2023
Decision Date 12/13/2023
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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