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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
Applicant
MEDTEC INC. DBA CIVCO MEDICAL SOLUTIONS
1401 8TH STREET SE
ORANGE CITY,  IA  51041
Applicant Contact AMANDA STAHLE
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
IYE  
Date Received05/25/2012
Decision Date 06/08/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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