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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 K171328
Device Name cNeuro cMRI
Combinostics Oy
Hatanpaan valtatie
Tampere,  FI 33100
Applicant Contact Lennart Thurfjell
Combinostics Oy
Hatanpaan valtatie
Tampere,  FI 33100
Correspondent Contact Lennart Thurfjell
Regulation Number892.2050
Classification Product Code
Date Received05/05/2017
Decision Date 01/08/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No