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510(k) Data Aggregation

    K Number
    K012886
    Device Name
    CBYON SYSTEM WITH IMAGE ENHANCED FLUOROSCOPY MODULE
    Manufacturer
    CBYON, INC.
    Date Cleared
    2001-10-09

    (42 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    CBYON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CBYON System with Image Enhanced Fluoroscopy Module intended use is as a computer-aided, image-guided system intended for planning and intraoperative navigation for cranial, spinal, and cranial biopsy procedures.
    Device Description
    Not Found
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    K Number
    K000171
    Device Name
    CBYON SURGICAL OPERATING SYSTEM (SOS)
    Manufacturer
    CBYON, INC.
    Date Cleared
    2000-03-13

    (53 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    CBYON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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