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510(k) Data Aggregation

    K Number
    K173588
    Device Name
    Illumeo System
    Manufacturer
    Philips Medical Systems Technologies, Ltd.
    Date Cleared
    2018-01-12

    (53 days)

    Product Code
    LLZ, JAK
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Philips Medical Systems Technologies, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Illumeo system is an image management system intended to be used by trained professionals, including but not limited to radiologists. Illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, manipulation and quantification of images, communication and storage. This device is not to be used for mammography.
    Device Description
    Illumeo is an image management system intended to be used by trained professionals, including but not limited to radiologists. Illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, manipulation and quantification of images, communication and storage. This device is not to be used for mammography. Illumeo is a medical software system offering a primary interpretation solution for visualization and evaluation a variety of medical images deriving from various imaging modalities as well as non-imaging information. Illumeo interconnects with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.
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