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510(k) Data Aggregation

    K Number
    K070713
    Device Name
    IMPLANT LOCATION SOFTWARE-T
    Date Cleared
    2007-05-02

    (49 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    TACTILE TECHNOLOGIES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Implant Location Software-T (ILS-T) is indicated for use by medically trained people as a software interface and image segmentation system for the transfer of imaging information from a CT scanner and as pre-operative software for simulating / evaluating dental implant positioning. Surgical templates may also be fabricated based on the output of the pre-operative planning.
    Device Description
    The Implant Location Software-T is a computer program (software) intended for use as an aid to the dental practitioners in the location of dental implants. The Implant Location Software-T-T (ILS-T) guides dental practitioners through the process of pre-operative planning their patients' dental implant surgery. Surgical templates may also be fabricated based on the output of the pre-operative planning. The system provides information but does not make any clinical decisions for the user. The software is supplied on disk-on-key. The Implant Location Software-T is designed to use images acquired from Computer Tomography (CT) scanners, present a graphical image of the planned implants as "virtual implants" on the CT images using DICOM interface standards, provide a summary report that gives planning information for the procedure, and allow user to consult on-line views of the plan during operation.
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    K Number
    K050341
    Device Name
    IMPLANT LOCATION SOFTWARE, MODEL 0.1.0
    Date Cleared
    2005-03-29

    (46 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    TACTILE TECHNOLOGIES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Implant Location Software (ILS) is indicated for use by medically trained people as a software interface and image segmentation system for the transfer of imaging information from a CT scanner and as planning software for dental implant placement.
    Device Description
    The Implant Location Software is a computer program (software) intended for use as an aid to the dental practitioners in the location of dental implants. The use as an all to the demal practitioners through the process through the process of Information bystem (120) gaan surgery. The system provides information but does not make any clinical decisions for the user. The software is supplied on disk-on-key. The Implant location Software is designed to use images acquired from The Implant Totation Boleval scanners, present a graphical image of the planned implants as "virtual implants" on the CT images using DICOM interface miplands, provide a summary report that gives planning information for the standards, provided buser to consult on-line views of the plan during operation.
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