510(k) Premarket Notification

• Device Classification Name: system, tomography, computed, emission
• 510(K) Number: K121019
• Device Name: OPTIMA NM/CT 640
• Applicant: GE HEALTHCARE; 4 hayozma street; tirat hacarmel,
• Contact: eli werner
• Regulation Number: 892.1200
• Classification Product Code: KPS
• Subsequent Product Code: JAK
• Date Received: 04/04/2012
• Decision Date: 04/19/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Radiology
• Review Advisory Committee: Radiology
• summary: summary
• Type: Traditional
• Reviewed by Third Party: Yes
• Expedited Review: No
• Combination Product: No