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510(k) Data Aggregation

    K Number
    K113082
    Device Name
    SONOVISION
    Date Cleared
    2012-03-08

    (142 days)

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

    PERIDOT TECHNOLOGIES NY INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Sonovision is a software application intended for capturing, viewing, archiving and management of images and study data, acquired from Ultrasound machine and other similar medical imaging systems, when installed on suitable commercial standard hardware. Sonovision is intended for use by obstetricians, gynecologists, radiologists, ultrasound technicians and cardiologists. The system is designed for use in hospitals, medical imaging labs and medical offices. Sonovision works as Workstation Software for Ultrasound Image Acquisition, Study Management, Reporting, Sending Studies to PACS Server or Making DICOM CD/DVD.
    Device Description
    Sonovision is an Ultrasound Imaging Solution/Ultrasound Workstation Software for images Acquisition. Study Management & Reporting. Sonovision capture's images and video clips from Ultrasound machine and save uncompressed images along with patient information to local database. - Saving, searching and loading Studies into secure local Database . - Save Studies as DICOM File, Image Files(JPG, J2K, TIFF and PNG) & Ultrasound . Reports - Send or Retrieve Studies to PACS Server over the network . - Make DICOM CD or DICOM DVD . - Use computer printer to print ultrasound images . - Image Zooming, Panning, Flipping, Rotating Options . - Add Text Annotations on Images . - Record Video Clips and covert them into DICOM Series/frames . Sonovision does NOT use lossy (irreversible) compression during image handling, manipulation or storage in local Database (It creates uncompressed TIFF Files). However when user converts images or series to DICOM or other Image formats(like JPG, PNG) manually then it may apply lossy (irreversible) compression on images. All hardware used by Sonovision 2.0 (Including computer, storage drives, network interfaces, video capture cards, monitors and printers) are commercial off-the-shelf equipment
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