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510(k) Data Aggregation

    K Number
    K102148
    Device Name
    CURIEPACS (DICOM PACS SOFTWARE)
    Date Cleared
    2010-08-17

    (18 days)

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

    MOKSHA DIGITAL SOFTWARE PVT LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CuriePACS (Dicom PACS Software) Software is a software device that receives digital images and data from various sources (Computed Radiography, Magnetic Resonance Imaging, Ultrasound, Endoscopy, Computed Tomography, Digital X-Ray Mammography, Nuclear Medicine Imaging, Secondary Capture, Radio Fluoroscopy, X-Ray or other Angiograms such as CT Angio). Images and data can he 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 that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA.
    Device Description
    CuriePACS is a comprehensive solution for Dicom imaging needs. This scalable PACS solution provides electronic viewing, storage and communication in a secure environment. The device consists of: 1. Dicom Server (MD Athena) - For storage and connectivity with all the modalities and 2. Image Viewer (MD Vision) - To connect to the server and retrieve images based on search criteria and other workflow requirements. Image modalities supported: CR. CT. DX. MG. MR. NM. RF. SC. US. XA (x-ray), and ES.
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