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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, x-ray, fluoroscopic, image-intensified
510(k) Number K121293
Model CS-10-FP THROUGH CS-65 FP (11 CONFIGURATION)
Device Name CS-SERIES-FP WITH 3030+OPTION
Original Applicant
OMEGA MEDICAL IMAGING, LLC
675 hickman circle
sanford,  FL  32771
Original Contact brian j fleming
Regulation Number892.1650
Classification Product Code
JAA  
Subsequent Product Code
OWB  
Date Received05/01/2012
Decision Date 07/26/2012
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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