BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Imager, Breast, Electrical Impedance

    PMA: P970033 · Supplement: S001 · Decision Nov 15, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Imager, Breast, Electrical Impedance
    Trade Name
    TS2000
    PMA Number
    P970033
    Supplement Number
    S001
    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
    November 15, 1999
    Date Received
    June 23, 1999
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changes in the electronic circuitry, elimination of all but the 200 Hz frequency, optional small probe, and optional phantom. The device is intended for use as an adjunct to mammography in patients who have equivocal mammographic findings within ACR BI-RADS(TM) categories 3 or 4. In particular, it is not intended for use in cases with clear mammographic or non-mammographic indications for biopsy. This device provides the radiologist with additional information to guide a biopsy recommendation.

    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