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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 K121545
Device Name BELLYBOARD, SBRT ACCESSORIES
Original Applicant
MEDTEC INC. DBA CIVCO MEDICAL SOLUTIONS
1401 8th street se
orange city,  IA  51041
Original Contact amanda stahle
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
IYE  
Date Received05/25/2012
Decision Date 06/08/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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