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510(k) Data Aggregation

    K Number
    K042408
    Device Name
    IQQA-CHEST SOFTWARE PACKAGE
    Manufacturer
    EDDA TECHNOLOGY, INC.
    Date Cleared
    2004-10-08

    (35 days)

    Product Code
    OMJ
    Regulation Number
    892.2050
    Why did this record match?
    Product Code :

    OMJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IQQA-Chest is a PC-Based, self-contained, non-invasive image analysis package used during the review of digital chest radiographic images. Combining image viewing, evaluation and reporting tools, the software is designed to support the physician in the identification of lung lesions (e.g. nodules), as well as the confirmation, evaluation and documentation of such physician-identified lesions. The IQQA-Chest software package supports a workflow based on automated segmentation for the visual identification of possible lesions. The tools also allow for regional analysis of possible lesions in terms of size, shape and position, thus aiding the physician in the characterization of physician-identified suspicious lesions. Image source: DICOM
    Device Description
    The IQQA-Chest Software Package is a self-contained, non-invasive thoracic radiographic image analysis package that is designed to run on standard PC hardware. Combining image viewing tools (e.g. image window level, pan, zoom, enhancement viewing), evaluation tools (e.g. automatic/interactive segmentation, quantitative measurements derived from marking and segmentation), and reporting tools (e.g. saved lesion, measurement information, physician-input nodule characterization, and etc), the software package is designed to support the physician in the identification of lung lesions (e.g. nodules), as well as the the physician in the laonificance or entation of such physician-identified lesions. The IQQA-Chest software package supports a workflow based on automated segmentation IQQA-Chost software package bapple lesions (nodule enhanced viewing). Based on physician's request, the tool segments locations in the lung area containing circular prysional o requeed, invites fulfiling intensity signal and circular shape constraints) that would typically correlate with lung nodules. The tools also allow for regional that would typessible lesions with respect to size, shape and position, aiding the anaryold or pobo characterization of physician-identified suspicious lesions.
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