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510(k) Data Aggregation

    K Number
    K143176
    Device Name
    UltraLinq
    Date Cleared
    2015-07-17

    (255 days)

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

    ULTRALINQ HEALTHCARE SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    UltraLinq is a software imagement system intended to receive, process, review, display, and archive medical images and data from imaging modalities (e.g. Ultrasound (US), and Magnetic Resonance (MR)). Images and data can be stored, communicated and displayed across computer systems and mobile devices. UltraLinq is a single system that can run on a web-enabled computer, iPad and iPhone and may be interfaced with other PACS systems. Diagnosis is not performed by the software but by qualified Physicians. Typical users of this system are trained and qualified professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants. UltraLinq is used to: - · share reports and studies with other UltraLinq users, - · review reports and studies, - · download and save reports and studies, - · send reports and studies to EMR and EHR systems, and - · route reports and studies to other UltraLinq users. UltraLinq provides access to medical images on mobile devices for non-diagnostic viewing and referral purposes. The mobile device access functionality is used for patient management by the medical community in order to access and display patient data, medical reports, and medical images. Mobile devices are not intended to replace full diagnostic workstations and should be used only when there is no access to a workstation. UltraLinq is also intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation. This measurement, available on workstations only, can be used to assist the clinician in cardiac evaluation. This device is not to be used for mammography.
    Device Description
    UltraLinq is a web-based software application that provides image processing and viewing tools and access to studies and reports from a web-enabled computer, iPad or iPhone. UltraLing is intended for use by a physician or other trained medical professionals to receive, process, review, display and archive medical images and data from imaging modalities. Diagnosis is not performed by the software but by qualified Physicians. UltraLinq is also intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation. This measurement, available on workstations only, can be used to assist the clinician in a cardiac evaluation. UltraLing conforms to the ACR/NEMA DICOM 3.0 standard for interoperability with other DICOM compliant systems.
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