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510(k) Data Aggregation

    K Number
    K042507
    Device Name
    UBIPACS
    Manufacturer
    Date Cleared
    2004-09-27

    (12 days)

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

    ICM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    UbiPACS™ by ICM Co. Ltd. is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Typical users of this system are trained professionals, i.e. physicians, radiologists, nurses, medical technicians, and assistants.
    Device Description
    The system is a server-based software application. UbiPacs™ is a distributed image management system that manages the archival, retrieval, and distribution of medical images within a Picture Archiving and Communication System (PACS) environment. UbiPacs™ provides network access to patients' current and historical radiological images and relevant examination data. The system is designed for facilitating the clinical practice of radiologists and physicians. UbiPacs™ implementation is based on the Digital Imaging and Communication in Medicine (DICOM) standard. The standard allows communications of images and relevant information such as patient demographics and examination data between the system and other DICOM-compliant imaging devices such as CT scanners, MR imager, CR systems, digital modalities and image viewing workstations.
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