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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 K213737
Device Name Quantib ND
Quantib B.V.
Westblaak 106
Rotterdam,  NL 3012KM
Applicant Contact Floor van Leeuwen
Quantib B.V.
Westblaak 106
Rotterdam,  NL 3012KM
Correspondent Contact Floor van Leeuwen
Regulation Number892.2050
Classification Product Code
Date Received11/29/2021
Decision Date 01/14/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No