Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS
• Generic Name: System, nuclear magnetic resonance imaging
• Regulation Number: 892.1000
• Applicant: General Electric Co.; P0 Box 414; Milwaukee, WI
• PMA Number: P830074
• Supplement Number: S005
• Date Received: 09/12/1985
• Decision Date: 08/04/1986
• Product Code: LNH
• Advisory Committee: Radiology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No