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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 K182564
Device Name Quantib ND
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 Received09/18/2018
Decision Date 12/27/2018
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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