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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 K121239
Device Name MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE
Original Applicant
OPTOACOUSTICS LTD
24301 woodsage drive
bonita springs,  FL  34134
Original Contact paul dryden
Regulation Number892.1000
Classification Product Code
LNH  
Date Received04/24/2012
Decision Date 05/24/2012
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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