Search Filters

Search Results

Found 6 results

510(k) Data Aggregation

    K Number
    K034051
    Device Name
    DYNATRAC, COD. 50-1A
    Manufacturer
    3D LINE USA, INC.
    Date Cleared
    2004-04-05

    (97 days)

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

    3D LINE USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is intended for localization of patient position in the conduct of radiation therapy with a linear accelcrator and registration of patient position between the planning and conduct of treatment. Patient Tracking System is an optical system for tracking patient position to linear accelerators used for before and during facilomeraly. It is an accessory of 3 dimensional radiotherapy.
    Device Description
    DynaTrac System Cod. 50-1A is a state-of-the-art optical tracking system that tracks patient position before and during a radiotherapy treatment session. It can track the patient in real time allowing the treatment system to respond to uncxpected movements. It shortens the time required to prepare a patient for a treatment session because of the speed with which spatial registration with a treatment plan can be confirmed.
    Ask a Question
    K Number
    K031281
    Device Name
    ERGO SRS
    Manufacturer
    3D LINE USA, INC.
    Date Cleared
    2003-12-23

    (245 days)

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

    3D LINE USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ERGO SRS is stcreotactic radiosurgery module for DMLCIV-ERGO (K001163). It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning of 3 dimensional radiation therapy.
    Device Description
    ERGO SRS is a stereotactic radiosurgery treatment planning software module for 3D Line USA's ERGO radiotherapy treatment planning system (K001163).
    Ask a Question
    K Number
    K031631
    Device Name
    STEREOTACTIC BODY FRAME, MODEL COD. 70-1A
    Manufacturer
    3D LINE USA, INC.
    Date Cleared
    2003-07-18

    (52 days)

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

    3D LINE USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Stereotactic Body Frame Cod. 70-1A is patient localization system for use in stereotactic radiosurgery. It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning and conduct of 3 dimensional radiation therapy.
    Device Description
    Stereotactic Body Frame is a spatial reference system external to the body of a patient undergoing radiotherapy treatment that provides accurate positioning of the patient in spatial registration with diagnostic images and a radiotherapy treatment plan.
    Ask a Question
    K Number
    K013535
    Device Name
    EVTOOL MODEL # V. 1.0
    Manufacturer
    3D LINE USA, INC.
    Date Cleared
    2002-01-18

    (87 days)

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

    3D LINE USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EVTOOL software module provides the ability to compare and evaluate the radiation dose delivery to the tumor volume and surrounding organs from generated dose volume histograms and radiobiological values. It expands the DMLC IV-ERGO system, which is a combination of a radiation collimator with multiple tungsten leaves that move during delivery of radiation therapy and a computer based treatment planning and control system.
    Device Description
    EVTOOL is a software module that has been designed to expand the features and functions of the DMLC IV- ERGO treatment planning software. The software runs on a silicon graphics workstation and Irix operating system. EVTOOL software is used for comparing and evaluating radiation therapy treatment plans from a quantitative and radiobiological point of view. The software displays one or more stored plans for comparison and analysis. It can display the dose volume histograms of the various plans and organ dose statistics (mean, modal, maximum and minimum dose). It allows the user to input radiobiological corrections in order to enhance the evaluation of the treatment plan. It also optimizes the dose prescription by displaying reference dose and number of treatment fractions. EVTOOL is fully integrated into the ERGO treatment planning environment in order to easily exchange information from the patients' database. The patient information is selected and automatically loaded into the EVTOOL software. From the patient database the user can select one or multiple treatment plans to display and calculate the dose statistics, including dose volume histograms and radiobiological models. The analytical information is displayed in 4 windows with a zoom capability. These windows can display the overall plan and individual organs of interest. EVTOOL provides options for incorporating radiobiological corrections to assist the physician in determining the optimal dose prescription and fractionation based on TCP (Tumor Control Probability), NTCP (Normal Tissue Complication Probability) and UTCP (Uncomplicated Tumor Control Probability) values. This software is a useful tool in evaluating the entire volumetric treatment plan, it is not used to directly treat the patient. It provides the physician with a tool to compare various plan versions side by side in order to determine the most appropriate treatment plan to be used with the DMLC IV equipment. The display of the treatment plans within EVTOOL provides a permanent record and effective control on the actual dose delivered to the patient.
    Ask a Question
    K Number
    K011255
    Device Name
    3D LINE STEROTACTIC HARDWARE ACCESSORIES
    Manufacturer
    3D LINE USA, INC.
    Date Cleared
    2001-12-20

    (240 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    3D LINE USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001163
    Device Name
    DMLC IV-ERGO
    Manufacturer
    3D LINE USA, INC.
    Date Cleared
    2000-10-23

    (196 days)

    Product Code
    IXI
    Regulation Number
    892.5710
    Why did this record match?
    Applicant Name (Manufacturer) :

    3D LINE USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1