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: DIASONICS NMR IMAGING SYSTEM
• Generic Name: System, nuclear magnetic resonance imaging
• Regulation Number: 892.1000
• Applicant: Diasonics, Inc.; 533 Cabot Rd.; S. San Francisco, CA 94080
• PMA Number: P830053
• Supplement Number: S013
• Date Received: 05/23/1985
• Decision Date: 07/10/1985
• Product Code: LNH
• Advisory Committee: Radiology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No