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510(k) Data Aggregation

    K Number
    K040486
    Device Name
    MEDIPACS
    Manufacturer
    Date Cleared
    2004-03-11

    (15 days)

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

    NEOBIT CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MEDIPACS™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, etc.). Images and data can be captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
    Device Description
    MEDIPACS™ handles and displays various objects in a Picture Archive and Communication System (PACS) environment. These objects can be images, requests, patients, examination etc. The system transmits digital electronic images and generates reports over a high-speed network to centralized storage. After transmission, patient information and images are available throughout the facility to many users simultaneously.
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