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510(k) Data Aggregation

    K Number
    K973413
    Device Name
    ID. STORE (RELEASE 2.0)
    Manufacturer
    I.S.G. TECHNOLOGIES, INC.
    Date Cleared
    1997-11-25

    (77 days)

    Product Code
    LMB
    Regulation Number
    892.2010
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ID. STORE (RELEASE 2.0)

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

    ID.Store is a software device intended to direct the lossless archival storage and retrieval, including the use of pre-fetching and auto-routing capabilities, of digital medical images within a Picture Archiving and Communications System (PACS).

    ID.Store may be used for the permanent storage and subsequent retrieval of any medical imaging data presented in DICOM or other supported format, within a Picture Archiving and Communications System (PACS).

    Device Description

    The ID.Store device is a software package composed of several application modules which work in tandem using a distributed storage architecture to control the archival storage and retrieval of digitized medical images. The ID.gate (gateway), ID.store (archiving), and ID.dbs (image database manager) modules communicate with each other using the dedicated administrative communication protocol ImageTalk. Permanent archival storage media supported include CD-R, WORM, MOD/WORM, DVD, etc. Recommended hardware are standard general purpose equipment, e.g. Sun Sparc or UltraSparc CPU's, and RAID devices for temporary data storage.

    AI/ML Overview

    The provided text does not contain detailed information about acceptance criteria or a specific study proving the device meets them. The document is primarily a 510(k) summary for the "ID.Store" device, focusing on its intended use, description, comparison to a predicate device, and regulatory approval.

    Specifically, the text is a 510(k) summary for the "ID.Store" (PACS Component Software) and letters from the FDA regarding its clearance. It describes the device's function as software for archival storage and retrieval of digital medical images within a PACS, and states its substantial equivalence to a predicate device (Kodak Medical Image and Information Library (MIIL)).

    Therefore, I cannot provide the requested information, which typically involves performance metrics, study design, and ground truth establishment. This type of information is usually found in detailed performance studies or validation reports, which are not part of this 510(k) summary.

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