Linea

All units of these models.

Radiology Devices

2

No

Worldwide Distribution.

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

Radiology Devices

2

No

Worldwide Distribution - USA including CA, DE, FL, IL, KY, LA, MA, MI, NE, NJ, NY, OH, PA, SD, TN, UT, WI, and WV.

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.

H14, H19, H27, H29. Serial Numbers:  H140927 H191045 H294986 H295004 H295021 H295036 H140929 H191048 H294988 H295010 H295025 H295042 H140932 H191049 H294989 H295012 H295031 H295047 H140934 H191050 H294999 H295013 H295032 H295051 H191035 H272973 H295001 H295014 H295033 H295058 H191044 H294979 H295002 H295015 H295034 H295068

Radiology Devices

2

No

Worldwide distribution: (USA) Nationwide including the states of PA. NJ, NY, MA, VA, TX, KS, FL, OH, SC, MN, CA, TN and NV; and the countries of Canada, Colombia, France, Italy, Japan, Netherlands and United Kingdom.

Clinac iX, 23EX, CX, DHXC, Novalis Tx, Trilogy and TrueBeam Linear Accelerators Drive Stands || Indicated for sterostatic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Model numbers H14, H27 and H29. Serial numbers: H140012 H140889 H140900 H140910 H140920 H140766 H140890 H140901 H140911 H140921 H140809 H140891 H140902 H140912 H140923 H140815 H140892 H140903 H140913 H140924 H140838 H140893 H140904 H140914 H140925 H140851 H140895 H140905 H140915 H140926 H140876 H140896 H140906 H140916 H140927 H140886 H140897 H140907 H140917 H140929 H140887 H140898 H140908 H140918 H140930 H140888 H140899 H140909 H140919 H140932 H270817 H271430 H271893 H272242 H290255 H271038 H271435 H271932 H272246 H290415 H271105 H271447 H271949 H272323 H291177 H271198 H271462 H271961 H272396  H271201 H271516 H271975 H272400  H271214 H271521 H271991 H272423  H271250 H271618 H272107 H272445  H271280 H271761 H272125 H272480  H271302 H271843 H272140 H290034  H271311 H271889 H272238 H290192

Radiology Devices

2

No

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.

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.

Coherence RT Therapist v2.1x - Part # 10652387; Coherence RT Therapist v2.2x - Part # 10652388.

Radiology Devices

2

No

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.

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.