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510(k) Data Aggregation

    K Number
    K103679
    Device Name
    AXIS PACS, HMS PACS
    Date Cleared
    2011-03-03

    (76 days)

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

    AXIS HEALTH CARE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    axis PACS is a software application intended to perform operations relating to acquisition, display, digital processing, review, transfer, archive, measurements, teleradiology exchange of medical images and patient demographic information. axis PACS receives digital images and data from various modalities, including but not limited to; Computed Radiography (CR), Computed Tomography (CT), Magnetic Resonance (MR), Ultrasound (US), Fluoroscopy (RF), secondary screen captures devices, scanners, digitizers, or other imaging sources. It is intended for use by the physician to aid diagnosis and used by medical professionals whenever they require access to medical images and patient demographic information. Users have access to a variety of measurement tools and image processing to aid them in viewing digital images. This device may be used to archive mammography images (MG) but is not intended for primary diagnostic viewing of mammography images. axis PACS can integrate with a health care institution's or physician's office Health Information System (HIS) or a Radiology Information System (RIS) for a fully integrated electronic patient record.
    Device Description
    axis PACS is a Picture Archiving and Communication System (PACS) designed for the management, and Procession, manipulation, and processing of DICOM 3.0 images from modalities in a diagnostic viewing, artiming, axis PACS consists of the axis PACS Web software application on a server and the axis imaging secting. "Alle Prob on client computers connecting to the Server via the HTTPS protocol. axis PACS r Nos viewer ver DICOM 3.0 images over a medical imaging network, as well as export images to other applications.
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