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VIEWRAY MRIdian System 4.5 - Default Chapter; Intended Use

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ViewRay Inc. MRIdian® system L-0009 Release 4.5 iii
CAUTION: The MRIdian® system is for PRESCRIPTION USE ONLY. Federal
law restricts the device to sale by or on the order of a physician, or
licensed healthcare provider.
Intended Use
The MRIdian system, with magnetic resonance imaging capabilities, is intended to provide
stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions
anywhere in the body where radiation treatment is indicated.
The MRIdian system may be contraindicated for patients with implants due
to the presence of the MRI magnetic field. All patients must be screened for
MRI compatibility prior t
o treatment.
The MRIdian system must be operated according to the intended use and only
by qualified persons with the necessary knowledge in accord with country-
specific regula
tions.
All personnel must complete user training before operating the system. The user must be
familiar
with all potential hazards and all safety guidelines. In addition, before using the
system, the user must read and understand the operators manual.
To find the software version your system is running Click > the MRIdian icon and a dropdown
menu op
ens. From that dropdown menu Click > About MRIdian®

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