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# Hitachi Device Cleared for Irradiating Tumors
- URL: https://www.fdaweb.com/hitachi-device-cleared-for-irradiating-tumors/
- Published: 2018-01-26T12:00:00.000Z
- Updated: 2026-09-14T23:17:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140614

FDA has cleared a Hitachi 510(k) for its Real Time Image Gating System for Proton Beam Therapy Systems” for treating cancer patients. The device uses proprietary technology to track and irradiate tumors in motion. “This is accomplished by positioning a gold marker 2mm in diameter, close to the tumor and establishing its location as a reference via computed tomography,” the company says. “A dual-axis, orthogonal X-ray system is used with pattern recognition software to determine the spatial location of the marker due to respiration. Irradiation during treatment is performed only when the gold marker moves to within millimeters of the planned irradiation location. This process, when repeated, can be synchronized to the respiratory motion of the patient. As a result, the harmful impact of irradiation to healthy tissue can be significantly reduced.”