Varian Medical Systems, Inc. Oncology Systems

Model number H19; serial numbers: H191001 H191061 H191121 H191180 H191002 H191063 H191122 H191181 H191003 H191064 H191123 H191182 H191005 H191065 H191124 H191183 H191006 H191066 H191125 H191184 H191007 H191067 H191126 H191185 H191008 H191068 H191127 H191186 H191009 H191069 H191128 H191187 H191010 H191070 H191129 H191188 H191011 H191071 H191130 H191189 H191012 H191072 H191131 H191190 H191013 H191073 H191132 H191191 H191014 H191074 H191133 H191192 H191015 H191076 H191134 H191194 H191016 H191077 H191135 H191195 H191017 H191078 H191136 H191197 H191018 H191079 H191137 H191198 H191019 H191080 H191138 H191199 H191020 H191081 H191139 H191201 H191021 H191082 H191140 H191202 H191022 H191083 H191141 H191203 H191023 H191084 H191142 H191205 H191024 H191085 H191143 H191206 H191025 H191086 H191144 H191207 H191026 H191087 H191145 H191209 H191027 H191088 H191146 H191210 H191028 H191089 H191147 H191213 H191029 H191090 H191148 H191215 H191030 H191091 H191149 H191221 H191031 H191092 H191150 H191225 H191032 H191093 H191151 H191226 H191033 H191094 H191152 H191227 H191034 H191095 H191153 H191228 H191035 H191096 H191154  H191036 H191097 H191155  H191037 H191098 H191156  H191038 H191099 H191157  H191039 H191100 H191158  H191040 H191101 H191159  H191041 H191102 H191160  H191042 H191103 H191161  H191043 H191104 H191162  H191044 H191105 H191163  H191045 H191106 H191164  H191046 H191107 H191165  H191047 H191108 H191166  H191048 H191109 H191167  H191049 H191110 H191168  H191051 H191111 H191169  H191052 H191112 H191170  H191053 H191113 H191171  H191054 H191114 H191172  H191055 H191115 H191174  H191056 H191116 H191175  H191057 H191117 H191176  H191058 H191118 H191177  H191059 H191119 H191178  H191060 H191120 H191179  ***AMENDED INFO***: H191208, H191211, H191214, H191217, H191219, H191220, H191222, H191223, H191224***

Radiology Devices

2

No

Worldwide Distribution - USA Nationwide and the countries ofAustralia, Belgium, Canada, China, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Italy, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom

True Beam; || Versions 1.0, 1.5.12.0 and below, 1.6.9.5 and below. || Varian Medical Systems, || Palo Alto, CA. || Product Usage: || TrueBeam Radiotherapy delivery system is intended to provide sterotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

Model number H19; Serial numbers: H191001 H191061 H191121 H191180 H191002 H191063 H191122 H191181 H191003 H191064 H191123 H191182 H191005 H191065 H191124 H191183 H191006 H191066 H191125 H191184 H191007 H191067 H191126 H191185 H191008 H191068 H191127 H191186 H191009 H191069 H191128 H191187 H191010 H191070 H191129 H191188 H191011 H191071 H191130 H191189 H191012 H191072 H191131 H191190 H191013 H191073 H191132 H191191 H191014 H191074 H191133 H191192 H191015 H191076 H191134 H191194 H191016 H191077 H191135 H191195 H191017 H191078 H191136 H191197 H191018 H191079 H191137 H191198 H191019 H191080 H191138 H191199 H191020 H191081 H191139 H191201 H191021 H191082 H191140 H191202 H191022 H191083 H191141 H191203 H191023 H191084 H191142 H191205 H191024 H191085 H191143 H191206 H191025 H191086 H191144 H191207 H191026 H191087 H191145 H191209 H191027 H191088 H191146 H191210 H191028 H191089 H191147 H191213 H191029 H191090 H191148 H191215 H191030 H191091 H191149 H191221 H191031 H191092 H191150 H191225 H191032 H191093 H191151 H191226 H191033 H191094 H191152 H191227 H191034 H191095 H191153 H191228 H191035 H191096 H191154  H191036 H191097 H191155  H191037 H191098 H191156  H191038 H191099 H191157  H191039 H191100 H191158  H191040 H191101 H191159  H191041 H191102 H191160  H191042 H191103 H191161  H191043 H191104 H191162  H191044 H191105 H191163  H191045 H191106 H191164  H191046 H191107 H191165  H191047 H191108 H191166  H191048 H191109 H191167  H191049 H191110 H191168  H191051 H191111 H191169  H191052 H191112 H191170  H191053 H191113 H191171  H191054 H191114 H191172  H191055 H191115 H191174  H191056 H191116 H191175  H191057 H191117 H191176  H191058 H191118 H191177  H191059 H191119 H191178  H191060 H191120 H191179   12/7/12 - Amended to include additional lot numbers: H191208, H191211, H191214, H191217, H191219, H191220, H191222 H191223, H191224.

Radiology Devices

2

No

Worldwide Distribution -- USA, and the countries of Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Netherlands, New Zealand, Norway, Portugal, Russia, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, and the United Kingdom.

TrueBeam and TrueBeam STx V1.0, 1.5, 1.6.95 and below. TrueBeam Radiotherapy Delivery System is intended to provide stereotactic radiosurgery and precision radiotherapy anywhere in the body where radiation treatment is indicated. Varian Medical Systems, Palo Alto, CA.

LIST OF SERIAL NUMBERS:  H140863 ,H294608 ,H294669 ,H294732 ,H140865 ,H294610 ,H294670 ,H294733 ,H140866 ,H294611 ,H294671 ,H294734 ,H140867 ,H294612 ,H294672 ,H294735 ,H140868 ,H294613 ,H294673 ,H294736 ,H140869 ,H294614 ,H294674 ,H294737 ,H140870 ,H294615 ,H294675 ,H294738 ,H140871 ,H294616 ,H294676 ,H294739 ,H140872 ,H294617 ,H294677 ,H294740 ,H140873 ,H294618 ,H294678 ,H294741 ,H140874 ,H294619 ,H294679 ,H294742 ,H140875 ,H294620 ,H294680 ,H294743 ,H140876 ,H294621 ,H294681 ,H294744 ,H140877 ,H294622 ,H294682 ,H294745 ,H140878 ,H294623 ,H294683 ,H294746 ,H140879 ,H294624 ,H294684 ,H294747 ,H140880 ,H294625 ,H294685 ,H294748 ,H140881 ,H294626 ,H294686 ,H294749 ,H140882 ,H294627 ,H294687 ,H294750 ,H140883 ,H294628 ,H294688 ,H294751 ,H140884 ,H294629 ,H294689 ,H294752 ,H140885 ,H294630 ,H294690 ,H294753 ,H140886 ,H294631 ,H294691 ,H294754 ,H140887 ,H294632 ,H294692 ,H294755 ,H140888 ,H294633 ,H294693 ,H294756 ,H140889 ,H294634 ,H294694 ,H294757 ,H140890 ,H294635 ,H294695 ,H294758 ,H140891 ,H294636 ,H294696 ,H294759 ,H140892 ,H294637 ,H294697 ,H294760 ,H140893 ,H294638 ,H294698 ,H294761 ,H140895 ,H294639 ,H294699 ,H294762 ,H140896 ,H294640 ,H294700 ,H294763 ,H140897 ,H294641 ,H294701 ,H294764 ,H140898 ,H294642 ,H294702 ,H294765 ,H140899 ,H294643 ,H294704 ,H294766 ,H140900 ,H294644 ,H294705 ,H294767 ,H181175 ,H294645 ,H294706 ,H294768 ,H181176 ,H294646 ,H294707 ,H294769 ,H181177 ,H294647 ,H294708 ,H294770 ,H181178 ,H294648 ,H294709 ,H294771 ,H181179 ,H294649 ,H294710 ,H294772 ,H181180 ,H294650 ,H294711  ,H181181 ,H294651 ,H294712  ,H181182 ,H294652 ,H294713  ,H181183 ,H294653 ,H294714  ,H181184 ,H294654 ,H294715  ,H181185 ,H294655 ,H294716  ,H181186 ,H294656 ,H294717  ,H181187 ,H294657 ,H294718  ,H181188 ,H294658 ,H294719  ,H181189 ,H294659 ,H294720  ,H181190 ,H294660 ,H294722  ,H181191 ,H294661 ,H294723  ,H181192 ,H294662 ,H294724  ,H182000 ,H294663 ,H294726  ,H182001 ,H294664 ,H294727  ,H182002 ,H294665 ,H294728  ,H182003 ,H294666 ,H294729  ,H182005 ,H294667 ,H294730  ,H294607 ,H294668 ,H294731

Radiology Devices

2

No

Worldwide Distribution.

Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. || 1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment i is indicated. (2) The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Radiology Devices

2

No

Worldwide Distribution - USA (nationwide) and Internationally. . .

Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 || Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA || The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eyes.

Model number: HIT Serial numbers: HIT0027 HIT1430R3 HIT2208R3 HIT3513 HIT2546 HIT2546 HIT2546 HIT0028 HIT1470M HIT2208R4 HIT3679 HIT2591 HIT2591 HIT2591 HIT0032 HIT1470R1 HIT2208R5 HIT3910 HIT2615 HIT2615 HIT2615 HIT0134 HIT1470R2 HIT2212 HIT3927M HIT2643 HIT2643 HIT2643 HIT0155 HIT1523M HIT2237M HIT3927R1 HIT2645 HIT2645 HIT2645 HIT0170M H1T1523R1 HIT2237R1 HIT3927R2 HIT2834 HIT2834 HIT2834 HIT0170R1 HIT1587M HIT2267M HIT3967 HIT2865 HIT2865 HIT2865 HIT0170R2 HIT1587R1 HIT2267R1 HIT4014 HIT2894M HIT2894M HIT2894M HIT0170R3 HIT1587R2 HIT2275M HIT4116 HIT2894R1 HIT2894R1 HIT2894R1 HIT0182 HIT1587R3 HIT2275R1 HIT4118M HIT2894R2 HIT2894R2 HIT2894R2 HIT0183 HIT1587R4 HIT2275R2 HIT4118R1 HIT2894R3 HIT2894R3 HIT2894R3 HIT0191M HIT1589M HIT2275R3 HIT4381 HIT2943 HIT2943 HIT2943 HIT0191R1 HITI589R2 HIT2275R4 HIT4555 HIT2953 HIT2953 HIT2953 HIT0191R2 HITI589R3 HIT2291M HIT4592 HIT2997 HIT2997 HIT2997 HIT0227 HIT1589R4 HIT2291R1 HIT4627 HIT3088M HIT3088M HIT3088M HIT0339M HIT1589R5 HIT2291R2 HIT4861 HIT3088R1 HIT3088R1 HIT3088R1 H1T0339R1 HIT1589R6 HIT2291R3 HIT4884 HIT3088R2 HIT3088R2 HIT3088R2 HIT0342 HIT1589R7 HIT2291R4 HIT4888M HIT3088R3 HIT3088R3 HIT3088R3 HIT0397 HIT1589R8 HIT2291R5 HIT4888R1 HIT3088R4 HIT3088R4 HIT3088R4 HIT0432M HIT1589R9 HIT2291R6 HIT4888R2 HIT3088R5 HIT3088R5 HIT3088R5 HIT0432R1 HIT1660M HIT2293 HIT4888R3 HIT3088R6 HIT3088R6 HIT3088R6 HIT0432R2 HIT1660R2 HIT2346M HIT4894 HIT3097 HIT3097 HIT3097 HIT0468M HIT1660R3 HIT2346R1 HIT4896 HIT3165 HIT3165 HIT3165 HIT0468R1 HIT1671 H1T2425 HIT4903 HIT3206 HIT3206 HIT3206 HIT0535 HIT1693 HIT2441 HIT4906 HIT3267 HIT3267 HIT3267 HIT0551 HIT1726 HIT2477M HIT4932M HIT1800 HIT2522 HIT0632M HIT1753 HIT2477R1 HIT4932R1 HIT0632R1 HIT1757 HIT2477R2 HIT4947 HIT0632R2 HIT1767M HIT2477R3 HIT4974 HIT0668 HIT1767R1 HIT2512M HIT4982 HIT0691M HIT1780 HIT2512R1 HIT5061 HIT0691R1 HIT2208R2 HIT3268 HIT0691R2.

Radiology Devices

2

No

Worldwide Distribution - Nationwide(USA) and including the countries of Australia, Denmark and the United Kingdom.

ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application.