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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
Original Applicant
ONI MEDICAL SYSTEMS, INC.
301 ballardvale st.
suite 4
wilmington,  MA  01887
Original Contact mark puopolo
Regulation Number892.1000
Classification Product Code
LNH  
Date Received01/08/2008
Decision Date 02/06/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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