510(k) Premarket Notification

• Device Classification Name: system, x-ray, angiographic
• 510(K) Number: K113034
• Models: INNOVA 21001Q, INNOVA 41001Q,INNOVA 31001Q,
• Device Name: GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM
• Applicant: GE HEALTHCARE; 9900 innovation drive; wauwatosa, WI 53226
• Contact: carol alloian
• Regulation Number: 892.1600
• Classification Product Code: IZI
• Date Received: 10/11/2011
• Decision Date: 12/13/2011
• 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