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510(k) Data Aggregation

    K Number
    K041326
    Device Name
    MEDCOMMONS OPEN RADIOLOGY GATEWAY
    Manufacturer
    MEDCOMMONS, INC.
    Date Cleared
    2004-07-27

    (70 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Abbreviated
    Panel
    Radiology
    Reference & Predicate Devices
    K020995,K012211
    Why did this record match?
    Device Name :

    MEDCOMMONS OPEN RADIOLOGY GATEWAY

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

    MedCommons Open Radiology™ Gateway (MedCommons Gateway™) is a software application for viewing medical images. Typical MedCommons Gateway™ users are healthcare professionals, such as, clinicians, radiologists, and technologists.

    MedCommons Gateway™ receives, communicates, and displays digital images and data from various types of imaging and image processing system, such CT, MR, US, RF units, computed and direct radiographic devices, scanners, imaging gateways and image processing sources). MedCommons Gateway™ can be integrated with an institution's HIS or RIS, linking or transferring images and data into electronic patient records.

    Device Description

    MedCommons Open Radiology™ Gateway (MedCommons Gateway™) is a component of a Picture Archiving and Communications System (PACS). MedCommons Gateway™ is a software application that provides image viewing and manipulation in a diagnostic imaging setting. The functions of this application are applied to medical images that are acquired and stored on an image server in DICOM and/or other proprietary formats. MedCommons Gateway™ can also transfer DICOM 3.0 images over a medical imaging network, as well as export images to applications in JPEG and/or proprietary formats.

    AI/ML Overview

    The provided text is a 510(k) summary for the MedCommons Open Radiology™ Gateway. This document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

    The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (eFilm Workstation) based on device description, intended use, and similar features. It is a regulatory submission for market clearance, not a report of a performance study with specific acceptance criteria.

    Therefore, I cannot provide the requested table and study details. The document explicitly states:

    • Substantial Equivalence: The MedCommons Open Radiology™ Gateway is substantially equivalent to the eFilm Workstation, which was cleared in 510(k)'s K020995 and K012211.
    • Comparison to the predicate device: The MedCommons Open Radiology™ Gateway and the eFilm Workstation are both software applications intended for viewing medical images stored in PACS systems. They have similar features and are substantially equivalent in safety and effectiveness.

    This indicates that the clearance was based on similarity to an already approved device, rather than a new clinical performance study with defined acceptance criteria and subsequent testing against them for this specific device.

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