FDA-Device2024-06-05Class II
RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a linear accelerator.
Reflexion Medical, Inc.
Hazard
A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
Sold states
U.S.: CA, CT, NJ, OR, PA and TX No O.U.S.
Affected count
7 systems
Manufactured in
25881 Industrial Blvd, Hayward, CA, United States
Products
RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a linear accelerator.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1933-2024Don't want to check this manually?
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