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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 K221106
Device Name Quantib Prostate
Applicant
Quantib BV
Westblaak 106
Rotterdam,  NL 3012 KM
Applicant Contact Arnault Massink
Correspondent
Quantib BV
Westblaak 106
Rotterdam,  NL 3012 KM
Correspondent Contact Arnault Massink
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/15/2022
Decision Date 05/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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