Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K232339
    Device Name
    Augmented Reality Application
    Manufacturer
    Date Cleared
    2024-02-01

    (181 days)

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

    Sira Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Sira Medical Augmented Reality Application is intended as a medical imaging system that allows the processing, review, analysis, and communication of augmented reality images acquired from the same data used to generate conventional CT scans and MRIs. Sira Medical software is designed for preoperative surgical planning and intended to be used by trained and qualified clinicians who are responsible for making patient management decisions.
    Device Description
    The Sira Medical Augmented Reality Application is used for viewing and manipulating 3D models created by the Sira 3D Image Preparation Service from customer-supplied anonymized (de-identified) imaging in Augmented Reality (AR) on a Head Mounted Display (HMD). The application allows the user to manipulate one or more 3D models in real time in an Augmented Reality (AR) environment. The user can view the model, adjust the orientation, scale, rotate and position the models within the AR visual space. Models can be sliced to create separate objects or merged together to create a single object. These models are used for preoperative surgical planning but are not used intraoperatively (during surgical procedures).
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1