ARTISTE and ONCOR Digital Linear Accelerators configured with the 160 leaf Multi-Leaf Collimator (MLC) and MEVATRON and PRIMUS Digital Linear Accelerators configured with the High Performance Defining Collimator (HPD); Product is manufactured by Kemnath, Germany-Siemens AG OCS and Siemens AG, Erlangen, Germany-Siemens AG OCS and distributed by Siemens Medical Solutions, Oncology Care Systems, Concord, CA; || Intended to deliver x-ray radiation for therapeutic treatment of cancer. || ARTISTE with 160 MLC, Part No.8139789, || ONCOR AG with 160 MLC, Part No.5863472 || ONCOR Impression || Plus with 160 MLC, Part No.5857912, || ONCOR Expression with 160 MLC, Part No.7360204, || ONCOR Expression with 160 MLC, Part No.7360717, || PRIMUS HI with HPD, Part No. 4504200, || MEVATRON M2 / PRIMUS Mid-Energy / HPD, Part No.1940035, || MEVATRON 6323-2 / HPD, Part No.19244500, || MEVATRON K2 / HPD, Part No.1940753, || MEVATRON PRIMART / HPD, Part No.5500371, || MEVATRON 77 / HPD, Part No.5659503, || MEVATRON M 7400 / 7440 (MEX) / HPD, Part No.5672977, || MEVATRON M 6700 (MX) / HPD, Part No.5693908, || MEVATRON M 6730 / HPD, Part No.5694005, || MEVATRON M 7140 / HPD, Part No.5694104, || MEVATRON M 7400 / HPD, Part No.5694153, || MEVATRON M 7445 / HPD (MEX), Part No.5694203, || MEVATRON K 7467 / HPD, Part No.5694252, || MEVATRON K 7767 / HPD, Part No.5694302, || MEVATRON K 8067 / HPD, Part No.5694401, || MEVATRON M 6300 (MX) / HPD, Part No.8317000, || MEVATRON M 6730/6740 (MEX) / HPD, Part No.8319758, || MEVATRON MD (MD, MDX) / HPD, Part No.8319808, || MEVATRON KD / HPD, Part No.8319857, || MEVATRON MDX / HPD, Part No.8496200, || MEVATRON KD-2 / HPD, Part No.8515520, || MEVATRON M3 6300 / HPD, Part No.9401316, || MEVATRON M2 6700 / HPD, Part No.9401407, || MEVATRON M2 6740 / HPD, Part No.9401506, || MEVATRON KDS / HPD, Part No.941522, || MEVATRON MD-2 / HPD, Part No.9401654, || MEVATRON MDX 2 / HPD, Part No.9401746, || MEVATRON KDS-2 / HPD, Part No.9411588, || MEVATRON KD-2 / HPD, Part No.9822685, || MEVATRON KDS-2 / HPD, Part No.9822693
Product Model Number ARTISTE MV System 8139789 ONCOR Avant Garde 5863472 ONCOR Impression 5857920 ONCOR Impression Plus 5857912 ONCOR Expression 7360204 and 7360717
Worldwide Distribution - USA including CA, DE, FL, IL, KY, LA, MA, MI, NE, NJ, NY, OH, PA, SD, TN, UT, WI, and WV.
Description du dispositif
ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). Linear Accelerators that may be affected are: || ARTISTE MV System; || ONCOR Avant Garde || ONCOR Impression || ONCOR Impression Plus || ONCOR Expression. || Manufactured by Siemens AG, Medical Solutions, Kemnath, Germany; || Registered by Siemens Medical Solutions, Concord, CA. || ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Worldwide Distribution -- USA (nationwide) and countries of: Australia, Columbia, Denmark, France, Ireland, Italy, Japan, Morocco, Poland, Portugal, Saudi Arabia, South Korea, Spain, and United Kingdom.
Description du dispositif
Clinac Linear Accelerator; || Model numbers H14, H27 and H29. || Product Usage: Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
Worldwide Distribution - USA including distribution to LA, CA, PA, MA, NE, NJ, DE, WI, NC, NY, WI, MD, FL, KY and to Poland, Netherlands, Ireland, G=Belgium, Germany, New Zealand, P.R. China, Saudi Arabia, Australia, Malaysia, Egypt, Canada, and Spain.
Description du dispositif
ONCOR/PRIMUS Linear Accelerator systems with RTT v2.x AND an ARTISTE Linear Accelerator/RT Therapist v4.1 system with the LANTIS OIS. || The Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Worldwide Distribution: Nationwide (USA) Distribution and the countries of; Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Belorussia, Bolivia, Bosnia and Herzegoniva, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Rep., Denmark, D.R. Ecuador, Egypt, Estonia, Finland, France, French Poly., Georgia, Germany, Greece, Guam, Guatemala, H.K., Honduras, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macau, Macedonia, Malaysia, Martinique, Mexico, Moldova, Monte Negro, Morocco, Nepal, Netherlands, N.Z., Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, P.R., Qatar, Reunion, Romania, Russia, S.A.,Serbia, Singapore, Slovakia, South Africa, S.K., Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad/Tobago, Tunisia, Turkey, Ukrain, U.A.E., U.K., Uruguay, Venezuela, Vietnam, V.I., and Zimbabwe.
Description du dispositif
Clinac, Trilogy. Trilogy Tx and Novalis Tx Linear Accelerators. || Varian Medical Systems, Inc. Oncology Systems || Intended for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions in the body where radiation treatment is indicated.