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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 K230772
Device Name Quantib Prostate
Quantib BV
Westblaak 130
Rotterdam,  NL 3012 KM
Applicant Contact Floor van Leeuwen
Quantib BV
Westblaak 130
Rotterdam,  NL 3012 KM
Correspondent Contact Floor van Leeuwen
Regulation Number892.2050
Classification Product Code
Date Received03/21/2023
Decision Date 04/17/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No