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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 K151466
Device Name MrOpen
Applicant
Paramed S.R.L.
Corso F. M. Perrone 73r
Genoa,  IT 16152
Applicant Contact Luisella De Benedetti
Correspondent
Paramed S.R.L.
Corso F. M. Perrone 73r
Genoa,  IT 16152
Correspondent Contact Luisella De Benedetti
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/01/2015
Decision Date 10/15/2015
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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