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: NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000
• Generic Name: System, nuclear magnetic resonance imaging
• Regulation Number: 892.1000
• Applicant: Philips Medical Systems (Cleveland), Inc.; 595 Miner Rd.; Cleveland, OH 44143
• PMA Number: P830052
• Supplement Number: S005
• Date Received: 08/28/1985
• Decision Date: 05/28/1986
• Product Code: LNH
• Advisory Committee: Radiology
• Supplement Type: Normal 180 Day Track
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No