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510(k) Data Aggregation

    K Number
    K961451
    Device Name
    DICOMNET
    Manufacturer
    LOCKHEED MARTIN COMMUNICATIONS SYSTEMS
    Date Cleared
    1996-07-03

    (78 days)

    Product Code
    IZI
    Regulation Number
    892.1600
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K943355
    Why did this record match?
    Device Name :

    DICOMNET

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

    DicomNet is intended to be used for storing and displaying digital images acquired and stored by digital imaging systems on DICOM interchange media. DicomNet reviews images directly from the DICOM storage media (CD-Recordable disks) and can store the images in an archive manager for review on any of the network review stations. The system stores unaltered/uncompressed computer digital data.

    Device Description

    DicomNet is composed of the following: Cardiac Review Station, Archive Manager, DLT Drive, Automatic Tape Library, RAID, ATM Switch.

    AI/ML Overview

    The provided text describes the DicomNet device, its components, indications for use, and a comparison to a predicate device (GEMnet). However, it does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot answer your specific questions as outlined in the prompt. The document primarily focuses on the device's description and its substantial equivalence to a predicate device, rather than performance metrics or a formal study.

    To answer your questions, I would need a document that includes:

    • Specific performance metrics (e.g., accuracy, sensitivity, specificity, processing speed, image quality standards).
    • Defined acceptance criteria for these metrics.
    • Details of a study conducted to evaluate these metrics against the acceptance criteria.
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