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510(k) Data Aggregation

    K Number
    K251577

    Validate with FDA (Live)

    Device Name
    LAIA XR
    Manufacturer
    Augmented Reality Software S.L.
    Date Cleared
    2026-02-06

    (260 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Age Range
    All
    Reference & Predicate Devices
    K213215
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    LAIA XR is a software device for displaying digital medical images, especially for CT and MR images (DICOM format). It is intended to visualize 3D medical imaging of the patient for pre-operative planning outside the surgical room.

    When accessing LAIA XR from a wired head-mounted display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diagnostic use. LAIA XR is indicated for use by qualified healthcare professionals including surgeons, radiologists, physicians, and technologists.

    Device Description

    LAIA XR is a software device for displaying digital medical images, especially for CT and MR images (DICOM format). It is intended to visualize 3D medical imaging of the patient for pre-operative planning outside the surgical room.

    When accessing LAIA XR from a wired head-mounted display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diagnostic use. LAIA XR is indicated for use by qualified healthcare professionals including surgeons, radiologists, physicians, and technologists.

    The device consists of a software-based medical system, which runs on a standard computing platform (e.g., a laptop or desktop computer) with a display screen. Optionally, the system can be used in conjunction with virtual reality (VR) goggles to provide an immersive three-dimensional (3D) visualization environment; however, the use of VR hardware is not required for the software to perform its intended functions.

    LAIA XR provides interactive visualization capabilities for three-dimensional medical images and includes functionalities and tools that support pre-operative planning activities, including the following:

    • Advanced 3D visualization of anatomical structures,
    • 2D and 3D multi-planar reconstruction views, with customizable transfer functions (color and opacity mappings) to highlight specific tissues or structures,
    • Quantitative measurement tools, such as distance and angle measurements,
    • Fiducial marker placement within defined regions of interest (ROIs),
    • Capture and screenshots of 3D models for use in surgical preparation,
    • Step-by-step surgical planning documentation, including written notes and screenshot capture.

    These functionalities allow healthcare professionals to interact with and organize medical imaging data as part of pre-operative planning workflows.

    The aim of the medical device software (MDSW) is to support healthcare personnel in the review and manipulation of CT and MR images. LAIA XR provides an interactive platform that allows users to view, manipulate, and organize medical image data for pre-operative planning purposes.

    AI/ML Overview

    N/A

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