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510(k) Data Aggregation

    K Number
    K022710
    Device Name
    SMARTPACS
    Date Cleared
    2002-10-11

    (58 days)

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

    TAIWAN ELECTRONIC DATA PROCESSING CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SmartPACS™ device is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstations, image storage and printing devices using DICOM or similar standards. Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.
    Device Description
    The SmartPACS™ system is a server-based software application. Smart PACS (SP) 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. The SP system provides online 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. The SP system 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 DICOMcompliant imaging devices such as CT scanners, MR imager, CR systems, and image viewing workstations.
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