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510(k) Data Aggregation
K Number
K973963Device Name
120 LEAF MULTILEAF COLLIMATOR
Manufacturer
MITSUBISHI ELECTRONICS AMERICA, INC.
Date Cleared
1998-01-14
(90 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
MITSUBISHI ELECTRONICS AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 120 Leaf MLC is indicated for use with the Mitsubishi EXL series linear accelerators to provide the ability to adjust the field shape to conform to tumor shapes. It can be a substitute for conventional customer blocks.
Device Description
This submission is intended to be applicable to the 120 Leaf multileaf collimator system (MLC) which can be used on Mitsubishi linear accelerators for external beam radiotherapy. The MLC system is design to provide the ability to adjust the field shape to conform to tumor shapes. It can be a substitute for conventional customer provided blocks. The MLC system consists of the collimator, the Local Control Equipment (LCE) located in the treatment room, and Multi Leaf Controller Unit (MLCU).
The collimator consists of three sets of jaws which determines the field size and shape. The top (Y-direction) jaws consist of a pair of monoblocks just like conventional accelerator therapy collimators. The middle (X-direction) jaws also consist of a pair of monoblocks. These jaws move in tandem and determine the field length.
The lower set of jaws consist of 60 pairs of leaves (120 leaves). Each pair of leaves is independently driven by a stepping motor. Each pair of leaves can be independently set to provide irregular-shaped field settings.
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K Number
K970564Device Name
DYNAMIC WEDGE
Manufacturer
MITSUBISHI ELECTRONICS AMERICA, INC.
Date Cleared
1997-05-12
(88 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
MITSUBISHI ELECTRONICS AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dynamic Wedge system is intended to be used with MLC and Mitsubishi linear accelerators with computerized consoles to provide the effective isodose curve and replace the need for traditional hard wedges.
Device Description
This submission is intended to be applicable to the Dynamic Wedge system which can be used with multileaf collimator system on Mitsubishi linear accelerators for external beam radiotherapy. The Dynamic Wedge system is designed to create effective isodose curve by using collimator leaf drive during irradiation. The Dynamic Wedge system consists of the collimator, motor drive unit (MDU), local control equipment (LCE) located in the treatment room, control console, and data management equipment (DME).
The collimator consists of two sets of jaws which determines the field size and shape. The upper jaws consist of a pair of monoblocks just like conventional accelerator therapy collimators. The upper jaws move in tandem and determine the field length.
The lower set of jaws consist of 31 pairs of leaves (62 leaves).
Each pair of leaves is independently driven by a stepping motor. Each pair of leaves can be independently set to provide irregular-shaped field settings.
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K Number
K970137Device Name
EXL-12SP,12DP,15DP,20DP LINAC
Manufacturer
MITSUBISHI ELECTRONICS AMERICA, INC.
Date Cleared
1997-04-15
(90 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
MITSUBISHI ELECTRONICS AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EXL series of accelerators are intended to be used for electron or photon radiation treatment of cancer.
Device Description
Medical Linear Accelerators provide a high energy beam of electrons and/or x-rays which is used for the treatment of cancer. The beam produced by the machine is carefully controlled in terms of geometry, energy, uniformity and intensity. The device also provides mechanisms for positioning the patient and controlling the delivery geometry.
The accelerators consist of three major subsytems, the Control Console. Gantry Stand, and Rotating Gantry.
The control console is the main component for operation and control of the LINAC. It is used to select the machine operation and patient treatment parameters and monitor the machine operating conditions. The new control console for the EXL-DP series of accelerators consists of an operator keyboard, video display, and various computers and control circuits.
The Gantry Stand contains the high power sources for the accelerator system, notably the Klystron microwave power, modulator and electromagnet power supplies,
The Rotating Gantry contains the accelerating tube, energy switching system, beam bending magnet, x-ray target, collimator, dosimetry system, and various safety features and circuits.
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