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Found 6 results
510(k) Data Aggregation
K Number
K034051Device Name
DYNATRAC, COD. 50-1A
Manufacturer
3D LINE USA, INC.
Date Cleared
2004-04-05
(97 days)
Product Code
IYE
Regulation Number
892.5050Why 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.
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K Number
K031281Device Name
ERGO SRS
Manufacturer
3D LINE USA, INC.
Date Cleared
2003-12-23
(245 days)
Product Code
MUJ
Regulation Number
892.5050Why 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).
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K Number
K031631Device 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
892.5050Why 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.
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K Number
K013535Device Name
EVTOOL MODEL # V. 1.0
Manufacturer
3D LINE USA, INC.
Date Cleared
2002-01-18
(87 days)
Product Code
MUJ
Regulation Number
892.5050Why 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.
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K Number
K011255Device Name
3D LINE STEROTACTIC HARDWARE ACCESSORIES
Manufacturer
3D LINE USA, INC.
Date Cleared
2001-12-20
(240 days)
Product Code
HAW
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
3D LINE USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001163Device Name
DMLC IV-ERGO
Manufacturer
3D LINE USA, INC.
Date Cleared
2000-10-23
(196 days)
Product Code
IXI
Regulation Number
892.5710Why did this record match?
Applicant Name (Manufacturer) :
3D LINE USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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