EXL-12SP,12DP,15DP,20DP LINAC

K970137 · Mitsubishi Electronics America, Inc. · IYE · Apr 15, 1997 · Radiology

Device Facts

• Record ID: K970137
• Device Name: EXL-12SP,12DP,15DP,20DP LINAC
• Applicant: Mitsubishi Electronics America, Inc.
• Product Code: IYE · Radiology
• Decision Date: Apr 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EXL series of accelerators are intended to be used for electron or photon radiation treatment of cancer.

Device Story

Medical linear accelerator (LINAC) for cancer radiation therapy; delivers high-energy electron/x-ray beams. System comprises control console, gantry stand, and rotating gantry. Input: operator-selected treatment parameters via keyboard/display. Transformation: computerized control console manages machine operation, beam geometry, energy, uniformity, and intensity; gantry stand houses klystron/magnetron power sources; rotating gantry contains accelerating tube, bending magnet, x-ray target, collimator, and dosimetry system. Output: controlled radiation beam for patient treatment. Used in clinical oncology settings by trained professionals. Output enables precise radiation delivery to tumor sites; benefits patient through targeted cancer treatment.

Clinical Evidence

Bench testing only; no clinical data provided. Substantial equivalence based on design comparison and maintenance of existing beam control, dosimetry, and interlock circuit performance.

Technological Characteristics

LINAC system; klystron/magnetron power supplies; computerized control console (keyboard/video display); rotating gantry with accelerating tube, beam bending magnet, x-ray target, collimator, and dosimetry system. No changes to beam generation/delivery hardware. Software-based control console replaces hard-wired interface.

Indications for Use

Indicated for patients requiring electron or photon radiation therapy for the treatment of cancer.

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• EXL series of Mitsubishi Linear Accelerators (utilizing klystron and magnetron power supplies and conventional hard-wired control consoles)

Submission Summary (Full Text)

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k990137

APR 15 1997

# 510 (k) SUMMARY

# MITSUBISHI LINEAR ACCELERATORS EXL SERIES

## 1. Submitter:

The 510 (k) is submitted by Mr. Hideyuki Kawakami, Sales Manager, Medical Systems Division, Mitsubishi Electronics America, Inc., Two Tower Bridge, 1 Fayette Street, Suite 100, Conshohocken, PA 19428. This 510 (k) summary was prepared on January 10, 1997.

## 2. Device Name:

The 510 (k) submission is for EXL series of Mitsubishi Linear Accelerators utilizing klystron and magnetron power supplies and computerized control consoles.

## 3. Predicate device:

The devices described in this submission are considered to be substantially equivalent to the EXL series of Mitsubishi Linear Accelerators utilizing klystron and magnetron power supplies and conventional hard-wired control consoles. The predicate device are legally marketed, having been found to be substantially equivalent through the 510 (k) premarket notification process.

## 4. 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 subsystems, 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.

## 5. Intended use:

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The EXL series of accelerators are intended to be used for electron or photon radiation treatment of cancer.

## 6. Comparison of technological characteristics:

This submission describes the modification of existing Mitsubishi EXL series of accelerators by the replacement of the conventional hard-wired operator console with the computerized console. There has been no change to the traditional treatment beam control circuit, dosimetry monitor circuit and interlock circuit from the currently marketed LINACS. Likewise, there has been no change in the function or performance specifications or characteristics. The technology used to set the operating parameters is transparent to the gantry and gantry stand where actual beam generation and delivery takes place.