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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 K233733
Device Name SyMRI
Applicant
Syntheticmr AB (Publ.)
Storgatan 11
Linköping,  SE SE-582 23
Applicant Contact Madeleine Enström
Correspondent
Syntheticmr AB (Publ.)
Storgatan 11
Linköping,  SE SE-582 23
Correspondent Contact Madeleine Enström
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/21/2023
Decision Date 03/26/2024
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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