510(k) Premarket Notification

• Device Classification Name: interventional fluoroscopic x-ray system
• 510(K) Number: K113027
• Device Name: SYNGO AORTIC VALVEGUIDE SOFTWARE
• Applicant: SIEMENS MEDICAL SOLUTIONS USA, INC.; 51 valley stream pkwy.; malvern, PA 19355
• Contact: patricia d jones
• Regulation Number: 892.1650
• Classification Product Code: OWB
• Subsequent Product Code: JAA
• Date Received: 10/11/2011
• Decision Date: 11/22/2011
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Radiology
• Review Advisory Committee: Radiology
• summary: summary
• Type: Special
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No