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510(k) Data Aggregation

    K Number
    K051813
    Device Name
    ULTRAPACS
    Date Cleared
    2005-08-15

    (41 days)

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

    ULTRARAD CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    UltraPACS™ system is device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. The device can also assists orthopedic surgeons when doing preoperative planning and post-operative follow-up. Options make possible reading (including mammography), telecommunications; fast demonstration; etc ; and teleconferencing. Lossy compressed or digitized screen film mammographic images must not be reviewed for primary image interpretations. Only FFDM manufacturer processed images in DICOM "For Presentation" format can be displayed for primary interpretation. Mammographic images must only be interpreted using a FDA approved monitor that offers at least 5Mpixel resolutions and other technical specifications reviewed and accepted by the FDA.
    Device Description
    UltraPACS™ makes possible the capturing, storage, distribution, and networking of medical images at distributed locations. In cases where DICOM images are not directly available to UltraPACS™, the system can acquire medical images using a DICOM gateway, which generates DICOM-type files. For example, film digitizers obtain images from old film and convert them to meet DICOM standards and stored in an archive. Stored files are transmitted using a network and can be viewed or manipulated from an imaging workstation. The orthopedic application is intended to assist orthopedic surgeons when doing preoperative planning and post-operative follow-up. The orthopedic application of the device is used to overlay prosthesis templates on radiological images, tools for repositioning the templates. and tools for measurements in the images.
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