BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Imager, Breast, Electrical Impedance

    PMA: P970033 · Supplement: S002 · Decision May 3, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Imager, Breast, Electrical Impedance
    Trade Name
    TRANSCAN T-SCAN 2000
    PMA Number
    P970033
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    NCL
    Generic Name
    Imager, breast, electrical impedance
    Medical Specialty
    Unknown
    Advisory Committee
    Radiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 3, 2000
    Date Received
    June 15, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of a protocol for a postapproval study to examine the effects of the mentrual cycle on the results of the device.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NCL Imager, Breast, Electrical Impedance