BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Imager, Breast, Electrical Impedance

    PMA: P970033 · Decision Apr 16, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Imager, Breast, Electrical Impedance
    Trade Name
    T-SCAN 2000
    PMA Number
    P970033
    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
    April 16, 1999
    Date Received
    July 16, 1997
    Expedited Review
    N
    Docket Number
    99M-1073

    Advisory Committee Statement

    Approval for the TransScan T-Scan 2000. The device is intended for use as an adjunct to mammography in patients who have equivocal mammographic finding within ACR BI-RADS (TM) categories 3 or 4. In particular, it is nnot 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