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510(k) Data Aggregation

    K Number
    K060263
    Device Name
    IQPACS
    Date Cleared
    2006-03-15

    (42 days)

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

    S.C. INFO WORLD S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    IQPACS™ is a software based 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. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. 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.
    Device Description
    IQPACS is a completely DICOM compliant PACS system, integrating the client and server applications in a clinic/hospital in a PACS network, facilitating the medical images management, offering quick access to radiological images, and making the diagnosing process easier. The IQPACS system consists of a number of applications that can be integrated in a PACS network, considering the client's needs and the specific of every clinical institution.
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