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510(k) Data Aggregation

    K Number
    K233660
    Device Name
    nCommand Lite System
    Manufacturer
    Date Cleared
    2024-03-18

    (124 days)

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

    Ionic Health

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The nCommand Lite system allows remote access for viewing/review of images as well as the ability to remotely provide real-time quidance to the licensed technologist operating a compatible MRI, CT, and PET-CT scanner. This access must be granted by the local licensed technologist operating the system. The remote access is only available for systems supporting remote connectivity capability. Images reviewed remotely are not for diagnostic use.
    Device Description
    The nCommand Lite system is a SaMD (Software as Medical Device) that is customer-facing and provides remote access through a web application for viewing images as well as the ability to remotely provide real-time guidance to the near-patient licensed technologist (local users) operating the medical imaging devices in the context of training, procedure assessment, for MN, CT, and PET-CT scanner. Remote users are licensed technologists and are able to access an imaging medical device from a computer that meets the minimum required specifications anywhere, using a secure software connection that streams video and mouse access. This allows remote users to assist local users with both remote and resoonsibilities being subject to local requlations where the imaging occurs. This access must by the local user using the system, and it can also be revoled at any time by the local user, thus allowing him/her to maintain complete control of the session at all times. Also, each remote session is controlled via a secure credential that is managed by the local user. Connections to a medical device are limited to one remote session at a time to maintain strict control over who is remotely interacting with the system. Images reviewed remotely are not for diagnostic use. n Command Lite is an IT hardware and software-based installation solution that supports multisesson, allowing remote technologists to view multiple medical imaging devices as needed. However, access is restricted to one medical imaging device at any given time, as only one keyboard and one mouse are provided. Scanners that are compatible with nCommand Lite system comply with a common protocol, allowing for scanning parameter management and remote scanning.
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