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510(k) Data Aggregation

    K Number
    K131873
    Device Name
    NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD)
    Manufacturer
    Date Cleared
    2013-09-25

    (93 days)

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

    METHODSENSE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NDOHD system is intended for viewing, acquiring, archiving and retrieving video and still images of endoscopic and fluoroscopic procedures. The professionals or practitioners using this system would be medical doctors or clinicians such as speech pathologists. The device is a prescription device. The NDOHD system is not intended to be used in an environment that requires sterilization.
    Device Description
    The NDOHD High Definition Imaging System (NDOHD) was initially commercialized in 2011 as a photographic accessory for endoscopes (FEM), Class I Exempt device. Altaravision has expanded the capabilities of the NDOHD system to include a computer and a camera, included a lossy image compression mechanism using standard irreversible compression technique, H.264, added a time code on the display of the image, created camera controls and added profiles for multiple camera settings and user preferences. Therefore, Altaravision has created a picture archiving and communication system that provides capabilities related to the acceptance, transfer, display, storage and digital processing of images and videos.
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