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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 K080048
Device Name MSK EXTREME MR SCANNER, MODEL AA5000
Applicant
ONI MEDICAL SYSTEMS, INC.
301 BALLARDVALE ST.
SUITE 4
WILMINGTON,  MA  01887
Applicant Contact MARK PUOPOLO
Correspondent
ONI MEDICAL SYSTEMS, INC.
301 BALLARDVALE ST.
SUITE 4
WILMINGTON,  MA  01887
Correspondent Contact MARK PUOPOLO
Regulation Number892.1000
Classification Product Code
LNH  
Date Received01/08/2008
Decision Date 02/06/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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