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510(k) Data Aggregation

    K Number
    K013630
    Device Name
    ISITE RADIOLOGY
    Manufacturer
    STENTOR, INC.
    Date Cleared
    2001-12-05

    (30 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K955092,K942120
    Why did this record match?
    Device Name :

    ISITE RADIOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Stentors' iSite Radiology is a medical image softcopy reading software package to be used for display of digital radiology images.

    Device Description

    iSite Radiology is designed as a Diagnostic reading workstation. iSite Radiology is capable of receiving and displaying DICOM images. Images sent to ISite Radiology are converted into formats suitable for viewing in its framework, and stored in a local cache. ISite Radiology is used by ISite Radiology to view JPEG and wavelet images follow known and accepted protocols. Images sent to ISite Radiology can be viewed using an executable that is installed on a Personal Computer equipped with the appropriate hardware. ISite Radiology uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack.

    AI/ML Overview

    The provided text is a 510(k) summary for the Stentor iSite Radiology software, specifically focusing on its substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

    The document primarily states that the iSite Radiology software is "designed, developed, tested and validated according to written procedures" and that "Extensive testing of the software package has been performed by programmers, by non-programmers, quality control staff, and by potential customers." However, it does not detail the nature, outcome, or specific metrics of these tests.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The document is a regulatory submission focused on demonstrating substantial equivalence, not a detailed technical report of performance testing.

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