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: INSTRUMENTARIUM ULF MR IMAGING SYSTEM
• Generic Name: System, nuclear magnetic resonance imaging
• Regulation Number: 892.1000
• Applicant: Palomex Instrumentarium Corp.; Helsinki, Finland; Helsinki, TX 22222
• PMA Number: P860010
• Supplement Number: S003
• Date Received: 01/20/1988
• Decision Date: 06/12/1988
• Product Code: LNH
• Advisory Committee: Radiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Other
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No