FDA-Device2024-09-18Class II
Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A
Hitachi America, Ltd., Particle Therapy Division
Hazard
During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.
Sold states
U.S. Nationwide distribution in the states of TN, TX, and WA.
Affected count
1
Manufactured in
2535 Augustine Dr, 2nd fl, Santa Clara, CA, United States
Products
Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3127-2024Don't want to check this manually?
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