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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 K122034
Device Name MRJ 3300
Applicant
Paramed S.R.L.
Corso F. M. Perrone 73r
Genoa,  IT 16152
Applicant Contact LUISELLA DEBENEDETTI
Correspondent
Paramed S.R.L.
Corso F. M. Perrone 73r
Genoa,  IT 16152
Correspondent Contact LUISELLA DEBENEDETTI
Regulation Number892.1000
Classification Product Code
LNH  
Date Received07/11/2012
Decision Date 12/06/2012
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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