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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
Applicant
Palodex Group Oy
Nahkelantie 160
Tuusula,  FI FI-04300
Applicant Contact Jouni Karkinen
Correspondent
Palodex Group Oy
Nahkelantie 160
Tuusula,  FI FI-04300
Correspondent Contact Jouni Karkinen
Regulation Number892.2050
Classification Product Code
LLZ  
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
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