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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
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