Sumitomo Proton Therapy System Clears FDA 510(k)

  Sumitomo Proton Therapy System Clears FDA 510(k)

Business Wire

TOKYO -- November 28, 2013

Sumitomo Heavy Industries, Ltd. (TOKYO:6302) announced today that it had
received US FDA 510(k) clearance of its Proton Therapy System. It is the first
510(k) cleared medical device for Sumitomo. Proton therapy is a form of
radiation therapy, which employs proton beams to kill cancer cells with better
dose distribution in comparison with conventional x-rays. Currently 12
facilities are operational and several more are under construction in the
United States, and the U.S. proton therapy market is expected to expand in the

Gantry Treatment System (Photo: Business Wire)

Gantry Treatment System (Photo: Business Wire)

Proton beam has a unique characteristic called the “Bragg Peak”. More
absorption dose is delivered as the proton loses its energy; consequently, the
maximum dose is deposited just before the beam stops, and there is no
radiation dose to normal cells behind the target tumor volume. This unique
characteristic is especially advantageous for cancers around critical organ
structures and pediatric cancers.

Sumitomo is one of the first proton system suppliers in the world, and it
delivered its first commercial system in 1997 to the National Cancer Center
Hospital East, Kashiwa, Japan. New projects are now under way in Taiwan,
Korea, and Japan. The System has a 230MeV proton accelerator (cyclotron) and
360 degree single or multiple rotating gantries with a proven and robust

“With 510(k) clearance, we have received a ticket for admission to the U.S.
market, but this is just the beginning of establishing a long term trusting
relationship with the equipment users such as hospitals, doctors and cancer
patients. The Sumitomo Proton Therapy System has an excellent track record and
keeps evolving in performance, function, and reliability with solid
technological experiences. We are hoping the Sumitomo Proton Therapy System
will be used to save many cancer patients in the U.S.,” said Yukio Kumata,
Vice President of Sumitomo Heavy Industries, Ltd.

Sumitomo Heavy Industries, Ltd. (

Sumitomo Heavy Industries, Ltd. (TOKYO:6302) is a technology-oriented Japanese
manufacturer of medical and industrial machinery. Its accelerator technology
is widely used in the semiconductor industry and in the nuclear physics
research sector as well as in medical applications. FY2012 annual sales is
$6.2 billion and the consolidate number of employees is approximately 18,000
worldwide. It belongs to Sumitomo Business Group.

Photos/Multimedia Gallery Available:



Sumitomo Heavy Industries (USA), Inc.
Shin Masui, +1-610-791-6716
Press spacebar to pause and continue. Press esc to stop.