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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 K162799
Device Name Cliniview
Palodex Group Oy
Nahkelantie 160
tuusula,  FI fi-04300
Applicant Contact jouni karkinen
Palodex Group Oy
Nahkelantie 160
tuusula,  FI fi-04300
Correspondent Contact jouni karkinen
Regulation Number892.2050
Classification Product Code
Date Received10/05/2016
Decision Date 04/25/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No