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

    SHIMADZU MULTI-DIRECTIONAL DIAGNOSTIC TABLE VS-100

    K Number: K913147 · Decision Sep 19, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    76
    Applicant Total
    90
    Review Days
    65

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    Basic Information

    Device Name
    SHIMADZU MULTI-DIRECTIONAL DIAGNOSTIC TABLE VS-100
    K Number
    K913147
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1980
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shimadzu Medical Systems
    Date Received
    July 16, 1991
    Decision Date
    September 19, 1991
    Product Code
    IXR
    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
    IXR Table, Radiographic, Tilting

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    K061643 ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO
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    K061641 ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO
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