MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK

Software Version 3.0.0 and after. Serial Numbers 201902, 203901, and 203919

Radiology Devices

2

No

Distributed in the states of NY, FL, and TX.

VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. || MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

Serial Numbers #s 201902 and 203901

Radiology Devices

2

No

Worldwide distribution: US (nationwide) including states of TX and FL; and countries of: Belgium, Italy, Japan and Korea.

MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical Linear Accelerator. || MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated

Serial Numbers: 201902, 201903, 202903, 202905, 203901, 203902, 203903, 203905, 203906, 203919 & 203924

Radiology Devices

2

No

Worldwide Distribution - US including FL, NY, OH, & TX, **Internationally - Belgium, Italy, Korea, France & Germany.

MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)

Software version 3.5.8, 3.5.2 and lower; Serial Numbers: 201902, 203901, 203919, 203924

Radiology Devices

2

No

Nationwide Distribution including New York, Texas, Florida, and Ohio

VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator || MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

Serial numbers: 201901, 201902, 201903, 201904, 201905, 202901, 202902, 202903, 202904, 202905, 202906, 203901, 203902, 203903, 203904, 203905, 203906, 203918, 203919, 203921, 203922, 203924, 203925, 203927 and 203929.

Radiology Devices

2

No

Distributed in the states of Florida, New York, Ohio & Texas, and the countries of France, Germany, Japan, Italy, Korea, & Belgium.

MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) || Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.