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510(k) Data Aggregation

    K Number
    K061418
    Device Name
    QUANTIVA
    Date Cleared
    2006-07-21

    (60 days)

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

    TOMOGRAPHIX IP LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Quantiva™is a software application intended to co-register and display 2D & 3D multimodality (CT & PET) medical images data. The medical practitioner can visualize, process, render, view, store, print and distribute DICOM 3.0 compliant medical image data within the system and/or across computer networks as distributed locations utilizing standard P.C. hardware. The volume and linear measurement functions are intended for evaluation and quantification of tumor measurements, location/displacement study, analysis and evaluation of both hard and soft tissue. The software also supports interactive segmentation of the region of interest, automated contouring of multi-slice ROI and labeling of avoidance structures during evaluation. Typical users of Quantiva™ are for trained professionals (including but not limited to: radiologists, clinicians and technicians). When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. The Quantiva™is indicated for use when it is necessary to acquire, record, review and distribute these images. The Quantiva™ is a prescription device. The labeling, instructions and user operations are designed for trained, licensed medical professionals.
    Device Description
    The Quantiva™ is a Class II software application intended to co-register anddisplay fused PET plus CT images enabling a qualified radiological technological technologist to visualize 2D & 3D multimodal (CT and PET) medical image data. The qualified user may process, render, view, store, and print DICOM 3.0 compliant medical image data within the system and/or across computer networks utilizing standard P.C. hardware and software.
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