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510(k) Data Aggregation

    K Number
    K243069
    Device Name
    LUMYS (V1)
    Manufacturer
    Date Cleared
    2025-05-02

    (217 days)

    Product Code
    Regulation Number
    892.2050
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    Applicant Name (Manufacturer) :

    INTRADYS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    LUMYS is intended for use as a software interface and image segmentation system, which is used to carry out presurgical planning tasks. LUMYS is intended to be used by clinicians with appropriate clinical judgement. LUMYS is a medical display software intended for 3D image visualization and image interaction. The stereoscopic 3D images are generated from 3D volumetric data acquired from a CT scan source. The device is intended to provide visual information to be used by clinicians with appropriate clinical judgement for analysis of surgical options, and the intraoperative display of the images. The primary surgeon wears a Microsoft Hololens™ Head Mounted Display (HMD) and consults with external users who can perform pre-surgical tasks such as annotating 3D images, uploading files and speaking with the surgeon. The surgeon must cease communication once surgery begins. LUMYS 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. LUMYS is intended to be used as a reference display consultation software, which assists the clinician with appropriate clinical judgement who is responsible for making all final patient management decisions.
    Device Description
    LUMYS is a data visualization standalone software that is used during medical procedures to visualize medical data and share this visualization with other healthcare professionals attending remotely the procedure. Different components are involved: - A Microsoft HoloLens 2 headset to access the data in the operating theater, - A broadcasting computer to broadcast video from a medical imaging device in LUMYS, - A web browser on a computer to access the data remotely. LUMYS is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. LUMYS is intended to be used by clinician with appropriate clinical judgement.
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