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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K162943
Device Name SyMRI
Applicant
SyntheticMR AB
Storgatan 11
Linkoping,  SE 582 23
Applicant Contact Maria Almesaker
Correspondent
Licensale Inc.
68 Southwoods Ter
Southbury,  CT  06488
Correspondent Contact Raymond Kelly
Regulation Number892.1000
Classification Product Code
LNH  
Date Received10/21/2016
Decision Date 08/29/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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