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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name image-intensified fluoroscopic x-ray system, mobile
510(k) Number K121303
Model XEPHILIO MC-1100
Device Name MOBILE C-ARM
Original Applicant
1201 richardson drive
suite 280
richardson,  TX  75080
Original Contact diane rutherford
Regulation Number892.1650
Classification Product Code
Subsequent Product Code
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