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510(k) Data Aggregation

    K Number
    K132799
    Device Name
    CLARISO PACS
    Manufacturer
    Date Cleared
    2013-11-07

    (62 days)

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

    CLARISO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CLARISO PACS is a software Teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. CLARISO PACS is used by hospitals, imaging centers, radiologist reading practices. CLARISO PACS is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only who are qualified to create and diagnose radiological image data.
    Device Description
    CLARISO PACS™ is a software system to be used to view DICOM compliant studies, which are stored within the CLARISO PACS™ . CLARISO PACS™ is intended for professional use only as a viewing tool for studies within a medical facility. CLARISO PACS™ is a 'Continuous Use' device. This device is also compliant with HIPAA regulations regarding patient privacy (such as restricting access to particular studies, logging access to data.). Since there is no direct patient interaction with the device, there is no possibility that CLARISO PACS™ might lead to a fatal fault or injury to the patient. The only two most likely causes of a fault would be the change of the computing environment of the Client system, or a mislabeling of the DICOM studies used by the Viewer. In the best-case scenario, CLARISO PACS™ would be able to operate safely in spite of such faults. The strategy of CLARISO PACS™ in fault handling is to keep its normal operation as much as it can. The CLARISO PACS™ is intended to work as a standalone service that provides common PACS functionality. The main objective of CLARISO PACS™ is to be a service that can be embedded in other applications that require PACS functionality. CLARISO PACS™ has four main uses: - Hard copy replacement: PACS replaces hard-copy based means of managing . medical images, such as film archives. - Remote access: It expands on the possibilities of conventional systems by providing . capabilities of off-site viewing and reporting (distance education, tele-diagnosis). It enables practitioners in different physical locations to access the same information simultaneously for teleradiology. - . Electronic image integration platform: PACS provides the electronic platform for radiology images interfacing with other medical automation systems such as Hospital Information System (HIS), Electronic Medical Record (EMR), Practice Management Software, and Radiology Information System (RIS). - . Radiology Workflow Management: PACS is used by radiology personnel to manage the workflow of patient exams.
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