BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR

    K Number: K953582 · Decision Sep 26, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    162
    Applicant Total
    7
    Review Days
    56

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    Basic Information

    Device Name
    HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR
    K Number
    K953582
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1700
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Varian Canada, Inc.
    Date Received
    August 1, 1995
    Decision Date
    September 26, 1995
    Product Code
    IZO
    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
    IZO Generator, High-Voltage, X-Ray, Diagnostic

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