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510(k) Data Aggregation

    K Number
    K080333

    Validate with FDA (Live)

    Device Name
    IMAGEGRID
    Manufacturer
    CANDELIS, INC.
    Date Cleared
    2008-02-22

    (15 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K012211,K052358
    Predicate For
    K092949,K124048
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ImageGrid™ is a software device and server that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources).

    ImageGrid™ is a PACS solution, including: ImageGrid Web Viewer, ImageGrid OrderEntry, ImageGrid RiS, and ImageGrid Mammography Web Viewer.

    Images (including mammography) and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.

    Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

    Device Description

    ImageGrid Web Viewer is a client/server software application and server that is designed to be used with the ImageGrid PACS device or as an independent service. The ImageGrid Web Viewer can query, retrieve, and display medical images that it retrieves from a DICOM SCP. The ImageGrid Web Viewer is a client/server software service that permits concurrent access to the ImageGrid PACS' medical images. ImageGrid™ can be integrated with an institutions HIS or RIS for an integrated electronic patient record.

    ImageGrid™ is a software device and server that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources).

    ImageGrid™ is a PACS solution, including: ImageGrid Web Viewer, ImageGrid OrderEntry, ImageGrid RIS, and ImageGrid Mammography Web Viewer.

    Images (including mammography) and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.

    Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, a study conducted, sample sizes, ground truth establishment, or expert involvement. The document is a 510(k) summary for ImageGrid™ PACS, primarily focusing on its description, intended use, and substantial equivalence to predicate devices, but lacks the specific details requested regarding performance validation.

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