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510(k) Data Aggregation

    K Number
    K232031
    Device Name
    LUNA 3D
    Date Cleared
    2024-03-29

    (266 days)

    Product Code
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAP GmbH Laser Applikationen

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LAP LUNA 3D system is used to support reproducible patient positioning and monitor patient surface motion during radiotherapy and radiosurgery treatments and during CT simulation for radiation therapy planning. LAP LUNA 3D may also be used to guide patients through breath-holds. The LAP LUNA 3D system can be used for all patients, undergoing radiotherapy and radiosurgery treatments and radiosurgery treatments and CT simulation for radiation therapy planning.
    Device Description
    The LUNA 3D optical camera system captures the current 3D patient skin surface with one or multiple camera pods. The software calculates the spacial deviations between the captured live surface and a reference surface within a selected region of interest using a registration algorithm. Reference surfaces may be generated with the optical camera system or may be imported using data received from Treatment Planning Systems (TPS). Based on the registration results the user can adjust the patient position for reproducible patient positioning relative to the treatment isocenter. During the imaging (simulation) and treatment delivery process, the system continuously calculates the deviations between live- and reference surface for patient motion monitoring to ensure that the patient position remains within pre-defined tolerances.
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    K Number
    K200907
    Device Name
    Thales 3D Mr Scanner
    Date Cleared
    2020-06-03

    (58 days)

    Product Code
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAP GmbH Laser Applikationen

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The THALES 3D MR SCANNER system is designed to measure the characteristic radiation beam for an irradiation unit. The beam data is stored in the software program and can be exported from there for use during commissioning in a treatment planning system (TPS) or for quality assurance. The THALES 3D MR SCANNER system can be used with irradiation units with integrated magnetic resonance imaging and a magnetic field of less than or equal to 0.35 tesla.
    Device Description
    The THALES 3D MR SCANNER system consists of a water phantom with a carriage system, a manual control unit and a software program. A water basin with the corresponding pump, a control unit with an electrometer, and a motor controller are integrated in the carriage system. The software program is used to control the three axes of the water basin, perform measurements and analyse measured data. The software program has the following properties: Acquisition of measured data, analysis, and recording of photon beams with the water phantom. Generation and export of beam data libraries for a treatment planning system (TPS) for commissioning of irradiation units. The software program is equipped with a central database and/or a file system for central storage of all recorded data for different irradiation units within a large hospital network with different sites. The software program offers the option of defining different user levels to support the typical clinical workflows.
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    K Number
    K173926
    Device Name
    DORADOnova MR3T
    Date Cleared
    2018-09-14

    (262 days)

    Product Code
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAP GmbH Laser Applikationen

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DORADOnova MR3T system assists in reproducible patient positioning during radiation therapy planning and is utilized during treatment planning workflow. The DORADOnova MR3T system projects visual laser beams which can be positioned at specified coordinates via a control system. The position coordinates are typically chosen by the operator or provided by an external system (e.g. treatment planning system). The DORADOnova MR3T system is allowed to be used in MR environment with a magnetic field, less or equal to 3 Tesla.
    Device Description
    The LAP moving laser positioning system contains laser devices and a control system. The laser system is provided in a configuration that enables the movement of two projection planes by using an appropriate composition of motorized and fixed laser devices. The installation of the system is realized in a combined bridge solution.
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