Computerized Medical Systems Inc

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.

Release 4.51.00

Radiology Devices

2

No

Worldwide Distribution -- United States (PA, AZ, CA, MN, OH, WI, NC, FL, TX, NY and WI), Australia, The Netherlands and India.

XiO Radiation Treatment Planning System, Release 4.51.00.

Release 2.03.00 and above.

Radiology Devices

2

No

Worldwide Distribution-- USA (nationwide) and countries of Austria, Australia, Belarus, Canada, China, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Mexico, Netherlands, Poland, Singapore, Slovenia, South Korea, Spain, Switzerland, Taiwan, Thailand and UK.

Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above. || The Monaco RTP system is used to create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed.

Monaco Release 2.03.00and above

Radiology Devices

2

No

Worldwide Distribution - USA (Nationwide distribution to AK, AZ, CA, CO, FL, IL, IN, MA, MI, MN, MO, NC, NM, NY, OH, OR, PA, SC, TX, VA, WA, and WI and the countries of Algeria, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Phillipines, Poland, Portugal, Singapore, Slovenia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, and the United Kindom.

Monaco Radiation Treatment Planning Workstation, Monaco Release 2.03.00 and above || To create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed.