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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 K193116
Device Name MRopen EVO
Applicant
ASG Superconductors S.p.A.
Corso Ferdinando Maria Perrone 73/R
Genova,  IT 16152
Applicant Contact DeBenedetti Luisella
Correspondent
ASG Superconductors S.p.A.
Corso Ferdinando Maria Perrone 73/R
Genova,  IT 16152
Correspondent Contact Luisella De Benedetti
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/12/2019
Decision Date 12/20/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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