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510(k) Data Aggregation

    K Number
    K210072
    Device Name
    HOLOSCOPE-i
    Date Cleared
    2021-05-14

    (123 days)

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

    Real View Imaging Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The HOLOSCOPE-i is a medical display workstation intended for 3D image visualization and image interaction. The holograms are generated from 3D volumetric data acquired from CT and Ultrasound sources. The device is intended to provide visual information to be used by the health care professional for analysis of surgical options, and the intraoperative display of the images. The HOLOSCOPE-i is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis. The HOLOSCOPE-i is intended to be used as a reference display for consultation to assist the clinician who is responsible for making all final patient management decisions.
    Device Description
    The HOLOSCOPE-i is a software-controlled optical system that displays 3D holographic medical images. The system generates color 3D holograms from 3D volumetric imaging datasets acquired from standard imaging modalities such as CT and 3D ultrasound. The HOLOSCOPE-i is comprised of an Optical Unit that creates the optical path for the generation of the holographic image; a system computer and electronics supporting the Human Machine Interactions (HMI) and a graphical user interface (GUI) display; a cart and boom mechanical fixture that mechanically connects the Optical Unit and the system computer; and a 3D Control Device for interfacing with the hologram.
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