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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 K192690
Device Name Upgrade Kit MR GUI PRO, MrJ 3300 Plus
Applicant
Asg Superconductors S.P.A.
Corso Ferdinando Maria Perrone 73/R
Genova,  IT 16152
Applicant Contact De Benedetti Luisella
Correspondent
Asg Superconductors S.P.A.
Corso Ferdinando Maria Perrone 73/R
Genova,  IT 16152
Correspondent Contact De Benedetti Luisella
Regulation Number892.1000
Classification Product Code
LNH  
Date Received09/26/2019
Decision Date 10/24/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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