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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K203582
Device Name QUIBIM Precision Prostate (qp-Prostate)
Applicant
QUIBIM S.L.
Avenida Aragón 30, 12th floor, Office I, 46021,
Valencia (Spain)
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
LLZ  
Date Received12/07/2020
Decision Date 02/04/2021
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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