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510(k) Data Aggregation

    K Number
    K022154
    Device Name
    LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D
    Manufacturer
    FISCHER INDUSTRIES, INC.
    Date Cleared
    2002-09-30

    (90 days)

    Product Code
    IXW
    Regulation Number
    892.1900
    Why did this record match?
    Applicant Name (Manufacturer) :

    FISCHER INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Level 356 X-Ray Film Processor is an automatic radiographic film processor, a diagnostic device intended to develope, fix, wash, and dry automatically and continuously film exposed for medical and dental purposes. This is the sole purpose of this device.
    Device Description
    Automatic Radiographic Film Processor. This film processor is operates like most predicate devices in that it uses a series of transport rollers to pull film through a series of open developer solution, fixer solution, and wash water tanks. Developer and fixer solution temperature is controlled automatically by a computer board. No plumbing is required.
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