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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 K203372
Device Name SyMRI
Applicant
SyntheticMR AB
Storgatan 11
Linkoping,  SE 582 23
Applicant Contact Lisa Warnroth
Correspondent
Licensale Inc
3422 Leonardo Lane
New Smyrna Lane,  FL  32168
Correspondent Contact Raymond Kelly
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/16/2020
Decision Date 11/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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