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510(k) Data Aggregation

    K Number
    K231897
    Manufacturer
    Date Cleared
    2025-10-21

    (846 days)

    Product Code
    Regulation Number
    882.4560
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Medivis NeuroAlign device is stereotaxic image guidance system intended to be used with the Microsoft HoloLens headset for the spatial positioning and orientation of neurosurgical instruments employed by surgeons. This device is specifically intended for cranial surgery, where reference to a rigid anatomical structure can be identified, without the need for a frame or fixation of a navigated instrument guide to the patient. The system is intended for use in various surgical settings, including operating rooms, intensive care units, and interventional procedure suites.

    Device Description

    The Medivis NeuroAlign device is a software application that processes and visualizes anatomical images for surgical navigation. It works in conjunction with off-the-shelf hardware and surgical instruments, including an IGS workstation, touchscreen monitor, and a 3D tracking system, along with IR trackable surgical instruments. The device uses pre-acquired patient data, which can be transferred from the hospital's PACS or local files. It operates with a network-based software interface for data downloading and supports image upload for custom visualization. The device's data transfer is unidirectional. It provides various image display options and manipulation features, primarily controlled through the touchscreen monitor. An HMD serves as an adjunct heads-up display and functions as an optical 3D tracking component for patient and surgical tool localization. The device registers patient data to the surgical environment through IR tracking, but it does not overlay data onto the surgical site. It cannot integrate with intra-operative image sources like surgical microscopes or ultrasound devices.

    AI/ML Overview

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