BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    X-RAY CONTROL & X-RAY HV GENERATOR

    K Number: K770338 · Decision Mar 1, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    162
    Applicant Total
    8
    Review Days
    11

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    Basic Information

    Device Name
    X-RAY CONTROL & X-RAY HV GENERATOR
    K Number
    K770338
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1700
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Litton Medical Systems
    Date Received
    February 18, 1977
    Decision Date
    March 1, 1977
    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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    Other Clearances by Litton Medical Systems

    K Number Device Name
    K770333 FLUOROSCOPE, C-ARM
    K770337 FLUOROSCOPIC ASSEMBLY, IMAGE INTENS.
    K770336 X-RAY TUBE, ROTATING ANODE
    K770334 TILTING X-RAY TABLE
    K770335 COLLIMATOR, AUTOMATIC
    K760568 SINGLE PHASE X-RAY CONTROLS & HV GENERATORS
    K760569 THREE PHASE X-RAY CONTROLS & HV GENERATORS