← Product Code [IYE](/productcode/IYE) · K122450 # MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS (K122450) _Mitsubishi Heavy Industries, Ltd. · IYE · Oct 3, 2012 · Radiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K122450 ## Device Facts - **Applicant:** Mitsubishi Heavy Industries, Ltd. - **Product Code:** [IYE](/productcode/IYE.md) - **Decision Date:** Oct 3, 2012 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.5050 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Therapeutic ## Indications for Use MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. ## Device Story MHI-TM2000 (Ver. 3.0) is a linear accelerator for radiation therapy. It builds upon the predicate MHI-TM2000 (K072047) by adding a communication interface to receive real-time position data from an external third-party system (Brainlab ExacTrac Vero). This data enables remote control of the device's existing gimbaled (pan and tilt) mechanism for the X-ray tube and multi-leaf collimator (MLC). By dynamically adjusting the beam axis, the device continuously aligns the treatment beam with moving targets during therapy. The system is operated by clinical staff in a radiation therapy environment. The primary benefit is improved precision in treating moving tumors. The core radiation generation and irradiation methods remain identical to the predicate. ## Clinical Evidence Bench testing only. Verification testing confirmed system specifications, functional requirements, use cases, and hazard mitigation. Accuracy of the gimbaled (pan and tilt) motion for continuous alignment with moving targets was verified against acceptance criteria. ## Technological Characteristics Linear accelerator system featuring X-ray-head-mounted gimbals for pan/tilt motion. Includes a new communication board interface for external position data integration. Operates as Image-Guided Radiation Therapy (IGRT) equipment. Software-controlled beam alignment. Sterilization and specific material standards not disclosed. ## Regulatory 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 - MHI-TM2000 Linear Accelerator System ([K072047](/device/K072047.md)) ## Reference Devices - ExacTrac Vero (Brainlab AG) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K12245D Image /page/0/Picture/1 description: The image shows the Mitsubishi logo, which consists of three red diamonds arranged in a triangular shape. Two diamonds are placed horizontally at the bottom, and one diamond is placed above them in the center. The logo is simple and recognizable, representing the company's brand identity. MITSUBISHI HEAVY INDUSTRIES. LTD. MACHINERY & STEEL INFRASTRUCTURE SYSTEMS **MACHINERY & STEEL INFRASTRUCTURE SYSTEMS** 6-22, 4-CHOME, KAN-ON-SHIN-MACHI, NISHI-KU HIROSHIMA, 733-8553 JAPAN OCT 3 2012 FI FPHONE +80-82-291-2153 FAX : +80-82-294-9888 ## 510(k) Summary The following information is provided following the format of 21 CFR 807.92 for the MHI-TM2000 Linear Accelerator System. - 1. Submitter: Mitsubishi Heavy Industries, Ltd. Machinery & Steel Infrastructure Systems 4-6-22 Kan-on-shin-machi. Nishi-ku, Hiroshima 733-8553 Japan - Contact person: Yoichi Wakiyama, Manager Quality Management Team Phone: +81-82-291-2135 Fax: +81-82-294-9878 E-mail: yoichi_wakiyama@mhi.co.jp Establishment Registration Number: 3006942329 Date prepared: July 20, 2012 - 2. Name of the Device: Trade / Proprietary Name: Common or Usual name: Classification Name: MHI-TM2000 Linear Accelerator System MHI-TM2000 Linear Accelerator System Clinical Linear Accelerator Medical Charged Particle Radiation Therapy System 21CFR 8892.5050 Class II Product Code: IYE #### 3. Predicate devices to claim substantial equivalence: 1) Mitsubishi Heavy Industries, Ltd. MHI-TM2000 Linear Accelerator System - K072047 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the Mitsubishi logo, which consists of three red diamonds arranged in a triangular shape. One diamond is at the top, and the other two are at the bottom left and right. The logo is simple and recognizable, and it is often associated with the Mitsubishi brand. MITSUBISHI HEAVY INDUSTRIES. MACHINERY & STEEL INFRASTRUCTURE SYSTE 6-22, 4-CHOME, KAN-ON-SHIN-MACHI. NISHI-KU HIROSHIMA. 733-8553 JAPAN TELEPHONE : +80-82-291-2153 FAX : +80-82-294-9888 #### 4. Intended Use Statement: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. #### 5. Description of the Device: The MHI-TM2000 Linear Accelerator System (hereinafter called "MHI-TM2000 (VER. 3.0)") has been developed based on MHI-TM2000 Linear Accelerator System previously cleared by FDA under K072047 (hereinafter called "MHI-TM2000 (K072047)"). MHI-TM2000 (VER. 3.0) introduces a new interface functionality for remotely controlling gimbaled motion (pan and tilt motion) of X-ray tube and MLC, based on position data received from radiation therapy positioning system "ExacTrac Vero", which is compatible 3rd party device manufactured by Brainlab AG. This functionality enables continuous alignment of treatment beam with moving target resulting in precise radiation treatment of moving targets. The gimbal mechanism (pan and tilt) is one of the unique characteristics of MHI-TM2000 (K072047), which is called "X-ray-head-mounted gimbals". The "X-ray-head-mounted gimbals" have been used to compensate for the residual mechanical deformation, mainly caused by gravity, but the MHI-TM2000 (VER. 3.0) utilizes this mechanism further for moving treatment-X-ray beam axis for continuously aligning it with moving target. A new interface (communication board) for receiving position data is equipped to System Controller Panel of MHI-TM2000 (VER. 3.0). The method of generating radiation and irradiation are the same as MHI-TM2000 Linear Accelerator System (K072047). ### 6. Substantial equivalence: The MHI-TM2000 (VER.3.0) is substantially equivalent to the predicate device: MHI-TM2000 Linear Accelerator System (K072047) of Mitsubishi Heavy Industries, Ltd., as Image-Guided Radiation Therapy Equipment. The intended use, indications for use, scientific technologies. 2/3 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a black and white logo. The logo consists of three diamond shapes arranged in a triangular pattern. One diamond is at the top, and two diamonds are at the bottom. MITSUBISHI HEAVY INDUSTRIES, LTD. MACHINERY & STEEL INFRASTRUCTURE SYSTEMS 6-22, 4-CHOME, KAN-ON-SHIN-MACHI, NISHI-KU HIROSHIMA, 733-8553 JAPAN TELEPHONE 80-82-291-2153 480-82-294-9888 materials, principles of operation and labeling, are the same or equivalent to MHI-TM2000 Linear Accelerator System (K072047). ### 7. Summary of Performance Testing: The verification testing results from bench testing support the substantial equivalence of the MHI-TM2000 (Ver. 3.0) with the predicate devices. The result also ensured conformance to system specifications, functional requirements, use cases, hazard mitigation, as well as compliance with applicable standards. Accuracy of gimbaled (pan and tilt) motion of X-ray tube and MLC (treatment beam axis) to continuously align with moving target, has also been tested because this is the key function for the new functionality. The results also showed that MHI-TM2000 (Ver.3.0) meet the acceptance criteria. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wing segments, representing health, human services, and the people served by the department. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle emblem. # DEPARTMENT OF HEALTH & HUMAN SERVICES - Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 Mr. Yoichi Wakiyama Manager, Quality Management Team Mitsubishi Heavy Industries, Ltd. Machinery & Steel Infrastructure Systems 4-6-22 Kan-on-shin-machi, Nishi-ku Hiroshima-shi 733-8553 JAPAN OCT 3 2012 Re: K122450 Trade/Device Name: MHI-TM2000 Linear Accelerator System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: August 3, 2012 Received: August 13, 2012 #### Dear Mr. Wakiyama: We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of {4}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 1 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely Yours, Janine M. Morris Director Bivision of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ MITSUBISHI HEAVY INDUSTRIES. LTD. MACHINERY & STEEL INFRASTRUCTURE SYSTEMS 6-22, 4-CHOME, KAN-ON-SHIN-MACHI, NISHI-KU HIROSHIMA, 733-8553 JAPAN TELEPHONE : +80-82-291-2153 FAX · +80-82-294-9888 # Indications for Use Statement K122450 510(k) Number (if known): Device Name: MHI-TM2000 Linear Accelerator System Indications for Use: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. Prescription Use _ X (Per 21 CFR § 801.109) Over-the-counter (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) OR (Division Sign-Off) (Division of Radiological Devices K122450 51uk --- **Source:** [https://fda-staging.innolitics.com/device/K122450](https://fda-staging.innolitics.com/device/K122450) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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