XIO RADIATION TREATMENT PLANNING SYSTEM

Sites affected will be those: 1. Running XiO Release 4.51 and higher, and 2. Using Elekta linacs, and 3. Using third party fixed wedges in combination with MLCs

Radiation Treatment Planning System

Versions 4.30.00, 4.31.00, 4.32.00, 4.33.00, 4.33.01, 4.33.02, 4.34.00, 4.34.01, 4.34.02, 4.40.00, 4.40.04, 4.40.05, 4.41.00, 4.41.01, 4.41.02, 4.42.00, 4.43.00, 4.44.01, 4.44.02, 4.44.03, 4.44.04, 4.45.00, 4.46.00, 4.46.01, 4.47.00, 4.50.00, 4.50.01, 4.50.02, 4.50.03, 4.50.04, 4.51.00, 4.51.01, 4.51.02, 4.60.00, 4.60.01, 4.61.00, 4.62.00, 4.62.01, 4.62.02, 4.62.03, 4.62.04, 4.62.05, 4.62.06, 4.63.00, and 4.64.00.

Radiology Devices

2

No

Worldwide Distribution - USA (nationwide) and the country of Canada

XiO Radiation Treatment Planning System, Versions 4.30.00-4.64.00. || Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two- or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.

Release 4.50.00 and above

Radiology Devices

2

No

Worldwide Distribution: USA, Canada, Australia, Spain, Italy, the Netherlands, United Kingdom, Taiwan, Malaysia, France, Ireland, and Israel.

Elekta XiO Radiation Treatment Planning System

XiO Release 4.0.0 through 4.40.00

Radiology Devices

2

No

Worldwide distribution: USA (nationwide) and countries of: China, France, Germany, Japan, Mongolia, Netherlands, Nicaragua, Poland, Russia, South Korea, Switzerland, and Turkey.

XiO Radiation Treatment Planning System, XiO Release 4.0.0 through 4.40.00 || Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.

XiO versions equal to or greater than 2.4.0 and less than 4.63.0

Radiology Devices

2

No

Worldwide distribution: USA (nationwide) including: IL, IN, MA, NJ and OK; and country of Germany.

XiO Radiation Treatment Planning System, XiO versions equal to or greater than 2.4.0 and less than 4.63.0 || The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.