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510(k) Data Aggregation

    K Number
    K152899
    Device Name
    Philips Lumify Diagnostic Ultrasound System
    Manufacturer
    PHILIPS HEALTHCARE, INC.
    Date Cleared
    2015-10-30

    (29 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHILIPS HEALTHCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, and Combined (B + Color) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: - Fetal/Obstetric Abdominal Urology Gynecological Cardiac Fetal Echo Small Organ Musculo-skeletal Peripheral Vessel Carotid Lumify is intended for use in environments where bealthcare is provided by healthcare professionals, with the exception of home, ambulance, or air.
    Device Description
    Lumify with the L12-4 transducer is a mobile, general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. Lumify supports wireless network connectivity to allow the user to export ultrasound images. The Lumify Diagnostic Ultrasound System includes: - o A commercial off-the-shelf Android device (COTS) - o Philips ultrasound software running as an app on the off-the-shelf device - o The C5-2 Curved linear array USB transducer - o The L12-4 Linear array USB transducer Eumify provides customers with a smaller, lower cost, and more easily leveraged ultrasound system.
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