510(k) Premarket Notification

• Device Classification Name: system, nuclear magnetic resonance imaging
• 510(K) Number: K121676
• Device Name: 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT
• Applicant: GE MEDICAL SYSTEMS, LLC; 3200 n. grandview blvd.; waukesha, WI 53188
• Contact: shashidhar cs
• Regulation Number: 892.1000
• Classification Product Code: LNH
• Subsequent Product Codes: LNI MOS
• Date Received: 06/07/2012
• Decision Date: 09/20/2012
• 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: Yes