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

    VASCO SCANNING BEAM DIGITAL X-RAY SYSTEM

    K Number: K982345 · Decision Sep 1, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    297
    Applicant Total
    2
    Review Days
    57

    Basic Information

    Device Name
    VASCO SCANNING BEAM DIGITAL X-RAY SYSTEM
    K Number
    K982345
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    CARDIAC MARINERS, INC.
    Date Received
    July 6, 1998
    Decision Date
    September 1, 1998
    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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