510(k) Premarket Notification

• Device Classification Name: image-intensified fluoroscopic x-ray system, mobile
• 510(K) Number: K121303
• Model: XEPHILIO MC-1100
• Device Name: MOBILE C-ARM
• Applicant: CANON, INC.-MEDICAL EQUIPMENT GROUP; 1201 richardson drive; suite 280; richardson, TX 75080
• Contact: diane rutherford
• Regulation Number: 892.1650
• Classification Product Code: OXO
• Subsequent Product Code: OWB
• Date Received: 05/01/2012
• 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