FDA-Device2014-12-03Class II
AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.
Vision Rt Inc
Hazard
Potential failure of AlignRT to assert interlock.
Sold states
Worldwide Distribution: US distribution in states of: CA, MN, TX, and UT; and internationally to: Republic of Ireland.
Affected count
7 (Six Units distribited in the US and One in OUS.)
Manufactured in
8840 Stanford Blvd, N/A, Columbia, MD, United States
Products
AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0464-2015Don't want to check this manually?
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