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: TESLACON(TM) NMR IMAGING SYSTEM
• Generic Name: System, nuclear magnetic resonance imaging
• Regulation Number: 892.1000
• Applicant: Technicare Corp.; P.O. Box 5130; Cleveland, OH 44101
• PMA Number: P830051
• Supplement Number: S010
• Date Received: 04/10/1986
• Decision Date: 10/01/1986
• Product Code: LNH
• Advisory Committee: Radiology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No