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510(k) Data Aggregation

    K Number
    K161341
    Device Name
    LIFESYS PACS
    Date Cleared
    2017-04-05

    (327 days)

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

    LIFETRACK MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    LifeSys™ PACS is a Picture Archive and Communications software product used to receive pertinent radiology patient information and DICOM images and allow easy generation of a Radiology Report for distribution over a network. LifeSys™ PACS software is intended for use as a primary diagnostic and analysis tool for diagnostic images. LifeSys™ PACS is for hospitals, imaging centers, radiologists, radiology professional services providers and any user who requires and is granted access to patient image, demographic and report information. The LifeSys™ PACS viewer displays images from CT, computed radiography, MRI, nuclear medicine. PET. ultrasound. x-rav angiography. and x-ray fluoroscopy.
    Device Description
    LifeSys™ PACS is a PACS software product that provides medical imaging departments of all types (Hospitals, Imaging Centers, and Clinics) with the capability to archive patient imaging studies and generate reports on said studies. LifeSys™ PACS is a single piece of software which includes the following functional modules: LifePACS™, which includes a Worklist, Tech Page, Image acquisition, receipt and archive, Report Editor, and tools for integration; and LifeView™, which includes a DICOM image viewer, rapid loading for fast and efficient reading and reporting and multiple monitor support.
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