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510(k) Data Aggregation

    K Number
    K031013
    Device Name
    INFINTT CO., LTD. STARPACS SYSTEM
    Manufacturer
    INFINITT COMPANY
    Date Cleared
    2003-04-17

    (17 days)

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

    INFINITT COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    STARPACS ™ is a device that receives digital images and data from various sources (i.e. 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. Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.
    Device Description
    STARPACS ™ is a server-based software application that is a distributed image management system that manages the viewing, retrieval, manipulation, and distribution of medical images within a Picture Archiving and Communication System (PACS) environment. The system provides online access to patients' current and historical radiological images and relevant examination data and is designed for facilitating the clinical practice of radiologists and physicians. STARPACS ™ implementation is based on the Digital Imaging and Communication in Medicine (DICOM 3.0) 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, and image viewing workstations.
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