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510(k) Data Aggregation

    K Number
    K190420
    Device Name
    NDOHD High Definition Imaging System (NDOHD)
    Manufacturer
    Date Cleared
    2019-04-15

    (53 days)

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

    Altaravision Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NDOHD system is intended for viewing, acquiring, recording, 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 NDOнd High Definition Imaging System (NDOнD) previously acquired FDA clearance in 2013 as a Class II picture archiving and communication system that provides capabilities related to the acquisition, transfer, display, storage, and digital processing of images and videos (K131873). Altaravision replaced off the shelf hardware components due to the hardware becoming obsolete. Altaravision also updated the NDOHD software to enable use of the new hardware, improve the software user interface and conform to Apple's latest coding best practices.
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