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510(k) Data Aggregation

    K Number
    K133357
    Device Name
    CHARRUAPACS SYSTEM
    Manufacturer
    Date Cleared
    2013-11-25

    (25 days)

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

    CHARRUASOFT SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CharruaPACS System™ is a software based device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, 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 cleared monitor.
    Device Description
    The CharruaPACS System™ consists of the CharruaPACS Workstation/Server and the DICOM Viewer (CWS). The device is a software system to be used to handle and view DICOM compliant studies, which are stored within the device or specified network locations. The System supports DICOM C-STORE SCP for most used SOP classes, with uncompressed Transfer Syntax and JPEG lossless, JPEG lossy and JPEG 2000 Transfer Syntaxes, C-FIND and C-MOVE SCP Study Root model and C-ECHO Verification as SCP. It is composed of four applications: Admin, DICOM Server, WEB Server, and HTTP Client. The servers run as Windows Services. It also uses the Independent JPEG group library for JPEG compression/decompression and the OpenJPEG group library for JPEG 2000 compression/decompression. The advanced version uses PostgreSQL as database. WebServer is based on Indy Project TIdHTTPServer. The CharruaPACS System™ is intended for professional use, as a viewing tool for imaging studies, and is a 'Continuous Use' device. This device is also compliant with HIPAA regulations regarding patient privacy. There is no direct patient interaction with the device. The CharruaPACS System is intended to work as a standalone service that provides common PACS functionality.
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