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510(k) Data Aggregation

    K Number
    K063253
    Device Name
    RCHIVE PACS
    Date Cleared
    2006-12-12

    (46 days)

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

    SOBHA RENAISSANCE INFORMATION TECHNOLOGY PVT LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    rChive™ PACS 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
    rChive™ PACS is a Picture Archival and Communication System (PACS), which facilitates image viewing at diagnostic, reporting, consultation and remote computer workstations, as well as archiving of pictures on magnetic or optical media using short or long-term storage devices. rChive™ PACS allows communication using local or wide-area networks, public communications services, systems that include modality interfaces and gateways to healthcare facility and departmental information systems.
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