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510(k) Data Aggregation

    K Number
    K960985
    Device Name
    SLS-CT
    Manufacturer
    BIO-IMAGING RESEARCH, INC.
    Date Cleared
    1996-10-25

    (239 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-IMAGING RESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SLS-CT is a data gathering device that allows the Radiographic Simulators to process data into tomographic images. The SLS-CT is not a diagnostic tool.
    Device Description
    The SLS-CT System manufactured by Bio-Imaging Research (BIR) is a passive add-on option to Philips Medical Systems, Inc.'s existing, legally marketed, Radiotherapy Simulators. The SLS-CT does not control the Simulator x-ray and mechanical functions. The SLS-CT is a data gathering device that allows the Radiographic Simulators to process data into tomographic images. The SLS-CT is not a diagnostic tool.
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