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510(k) Data Aggregation

    K Number
    K012844
    Device Name
    MAROSIS PACS
    Manufacturer
    MAROTECH, INC
    Date Cleared
    2001-11-08

    (77 days)

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

    MAROTECH, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Marosis™ PACS System is a device that receives digital images and data from various sources (including but not limited to 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.
    Device Description
    The Marosis™ PACS product handles various objects in a Picture Archive and Communication System (PACS) environment. These objects can be images, requests, patients, examination etc. Marosis™ PACS 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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