LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K121466
    Device Name
    GUIDEMIA
    Manufacturer
    GUIDEMIA TECHNOLOGIES, LLC
    Date Cleared
    2012-05-31

    (14 days)

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

    The GuideMia system is intended as software interface to transfer DICOM images generated by CT scanners, an image segmentation system to create dental anatomies from scan images, and a preoperative software for simulating/evaluating dental implant placement and surgical treatment options.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "GuideMia Software System". It does not contain information about the acceptance criteria and study results for the device. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information based on the given input document. If you have a different document that details the acceptance criteria and study that proves the device meets them, please provide it.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1