BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    FLUOREX DTA-400A

    K Number: K946081 · Decision May 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    297
    Applicant Total
    145
    Review Days
    162

    Basic Information

    Device Name
    FLUOREX DTA-400A
    K Number
    K946081
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
    Date Received
    December 13, 1994
    Decision Date
    May 24, 1995
    Product Code
    JAA
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JAA System, X-Ray, Fluoroscopic, Image-Intensified

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