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510(k) Data Aggregation

    K Number
    K123070
    Device Name
    GALILEOS FAMILY
    Manufacturer
    SIRONA DENTAL SYSTEMS GMBH
    Date Cleared
    2013-03-15

    (165 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K060892,K120263
    Why did this record match?
    Device Name :

    GALILEOS FAMILY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Devices of the GALILEOS family consist of an x-ray system that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volume reconstructions of the head area, which includes ENT and dentomaxillofacial areas, for use in planning and diagnostic support in adult and pediatric care.

    Devices of the GALILEOS family comprise a package of PC software modules to expand SIDEXIS capabilities to handling 3D data. This includes 3D reconstruction, storage, retrieval, viewing and processing of 3D-image data.

    Device Description

    The GALILEOS family is an extraoral source dental X-ray system intended to produce Xrays for obtaining three dimensional volume reconstructions of the teeth, jaw, and the head area, which includes ENT and dentomaxillofacial areas, for use in planning and diagnostic support in adult and pediatric care.

    The GALILEOS family device generates a conical x-ray beam that rotates around the patient's head within a certain angle.

    The device comprises an image receptor for 3D volume exposure with an adjustable diaphragm. Three volume regions are defined through this. Class I laser beam light localizers serve to position the patient's head that may be fixed through bite block and adjustable forehead and temple supports.

    From the obtained exposures a three dimensional image is reconstructed and can be viewed as well as panoramic/cephalometric images. The constructed 3D volume and simulated projection exposures as well as panoramic/cephalometric data are conveyed to SIDEXIS and stored in the SIDEXIS data base.

    An operator control panel allows height adjustment, selection of mode and program, and indicates machine states.

    A separate handhold push-button serves for exposure release An optional remote control is available.

    AI/ML Overview

    The provided text describes a 510(k) submission for the Sirona Dental Systems GALILEOS family of devices but does not include any acceptance criteria or details of a study demonstrating the device meets such criteria.

    The submission states:

    • "Nonclinical Testing" involved system functions testing, which "covers the requirements from the function specification, the risk/hazard analysis and the functionality of the equipment from the user's perspective." Additionally, "The exposure programs have been tested utilizing test phantoms. The tests evaluate the equality of exposures of proposed GALILEOS family and predicate device GALILEOS."
    • "Clinical Testing": "Clinical tests have not been performed."

    Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this information is not present in the provided text. The submission relies on demonstrating substantial equivalence to a predicate device, as highlighted by the conclusion: "Based on a comparison of intended use, indications, construction materials, principle of operation, features, and technical data, the Sirona Dental GALILEOS family and the new member GALILEOS Comfort" is safe and effective to perform its intended use and is substantially equivalent to the predicate devices."

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