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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 K202501
Device Name Quantib Prostate
Applicant
Quantib BV
Westblaak 106
Rotterdam,  NL 3012 KM
Applicant Contact Floor van Leeuwen
Correspondent
Quantib BV
Westblaak 106
Rotterdam,  NL 3012 KM
Correspondent Contact Floor van Leeuwen
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/31/2020
Decision Date 10/11/2020
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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