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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 K120701
Device Name M2 WRIST MRI SYSTEM
Original Applicant
ASPECT IMAGING LTD
20 hata'as st
(opb 124)
kfar saba,  IS 44425
Original Contact ahava stein
Regulation Number892.1000
Classification Product Code
LNH  
Date Received03/07/2012
Decision Date 02/07/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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