Treatment planning system

Radiology Devices

2

No

Worldwide distribution: USA (nationwide) and countries including of: Austria, Australia, Bahrain, Belgium, Brazil, Canada, China, Chile, Colombia, Denmark, Egypt, Finland, France,Germany, Greece, Hungary, Hong Kong, India, Indonesia, Israel, Ireland, Italy, Japan, Latvia, Malaysia, Mexico, Morocco, Nepal, Netherlands, Norway, Panama, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, United Kingdom, Taiwan, Turkey, Ukraine, United Arab Emirates and Venezuela.

Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; 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 algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.

Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years.

Radiology Devices

2

No

Worldwide distribution: USA (nationwide) including states of: FL, MA, NJ, and NY; and countries of: Canada Germany, Netherlands and Switzerland.

Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. || RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.

H480044 , H481353 , H482733 , H484585 , H485948 , H480045 , H481354 , H482734 , H484634 , H486024 , H480105 , H481433 , H482765 , H484673 , H486032 , H480106 , H481436 , H482827 , H484677 , H486093 , H480159 , H481437 , H482858 , H484680 , H486094 , H480160 , H481451 , H482859 , H484745 , H486095 , H480247 , H481452 , H482860 , H484746 , H486114 , H480301 , H481453 , H482888 , H484747 , H486140 , H480373 , H481454 , H482889 , H484753 , H486209 , H480374 , H481460 , H482897 , H484830 , H486291 , H480378 , H481461 , H483087 , H484842 , H486369 , H480379 , H481462 , H483204 , H484856 , H486385 , H480408 , H481483 , H483345 , H484950 , H486412 , H480409 , H481532 , H483350 , H484951 , H486442 , H480410 , H481533 , H483351 , H48SOOS , H486473 , H480422 , H481581 , H483352 , H485006 , H486486 , H480471 , H481582 , H483353 , H485090 , H486498 , H480477 , H481601 , H483354 , H485091 , H486499 , H480493 , H481627 , H483406 , H485113 , H486543 , H480566 , H481639 , H483442 , H485127 , H486579 , H4806Sl , H481685 , H483452 , H485143 , H486580 , H480692 , H481766 , H483592 , H485144 , H486615 , H480725 , H481781 , H483617 , H485145 , H486616 , H480764 , H481807 , H483666 , H485162 , H486688 , H480765 , H481815 , H483695 , H485244 , H486689 , H480766 , H481834 , H483696 , H485268 , H486694 , H480794 , H481857 , H483698 , H485308 , H486703 , H480808 , H481879 , H483723 , H485321 , H486716 , H480819 , H481923 , H483724 , H485322 , H486759 , H480820 , H481924 , H483725 , H485359 , H486760 , H480821 , H482166 , H483732 , H485442 , H486858 , H480917 , H482167 , H483733 , H485471 , H486859 , H480918 , H482168 , H483757 , H485481 , H486860 , H481054 , H482181 , H483758 , H485536 , H486861 , H481057 , H482182 , H483759 , H485537 , H486885 , H481112 , H482191 , H483767 , H485541 , H486895 , H481114 , H482192 , H483768 , H485557 , H486896 , H481119 , H482193 , H483840 , H485573 , H486938 , H481120 , H482194 , H483841 , H485580 , H486939 , H481133 , H482243 , H483871 , H485581 , H486941 , H481138 , H482244 , H483872 , H485582 , H486957 , H481154 , H482246 , H483943 , H485592 , H487011 , H481155 , H482266 , H483967 , H485595 , H487012 , H481164 , H482267 , H483968 , H485628 , H487277 , H481165 , H482323 , H483969 , H485689 , H487278 , H481166 , H482367 , H483993 , H485694 , H487279 , H481168 , H482385 , H484008 , H485706 , H487302 , H481171 , H482386 , H484023 , H485729 , H487428 , H481172 , H482387 , H484056 , H485776 , H487512 , H481196 , H482388 , H484153 , H485777 , H487513 , H481206 , H482391 , H484154 , H485792 , H487580 , H481207 , H482579 , H484168 , H485800 , H487621 , H481208 , H482580 , H484169 , H485890 , H487639 , H481211 , H482581 , H484274 , H485891 , H487698 , H481218 , H482638 , H484367 , H485892 , H487700 , H487771 , H48A323 , H48B875 , H48C805 , H487772 , H48A398 , H48B887 , H48C806 , H487775 , H48A462 , H48B898 , H48C807 , H487778 , H48A474 , H488899 , H48C808 , H487895 , H48A482 , H48B900 , H48C809 , H487950 , H48AS12 , H48C084 , H48C854 , H487980 , H48AS13 , H48C085 , H48C8SS , H487999 , H48ASSS , H48C086 , H48C866 , H488005 , H48AS87 , H48C116 , H48C881 , H488029 , H48AS90 , H48C120 , H4800Sl , H4880SS , H48AS91 , H48C121 , H480113 , H488102 , H48AS92 , H48C134 , H480118 , H488163 , H48AS93 , H48C135 , H480171 , H488210 , H48AS94 , H48C136 , H48D177 , H488211 , H48AS95 , H48C137 , H48D179 , H488229 , H48A612 , H48C138 , H48D187 , H488237 , H48A614 , H48C173 , H48D211 , H488238 , H48A713 , H48C174 , H48D235 , H488243 , H48A760 , H48C176 , H48D315 , H488249 , H48A762 , H48C212 , H48D316 , H488291 , H48A816 , H48C252 , H48D317 , H488311 , H48A818 , H48C253 , H48D318 , H488312 , H48A890 , H48C278 , H480319 , H488483 , H48A918 , H48C316 , H480320 , H489074 , H48A920 , H48C356 , H480321 , H489079 , H48A956 , H48C367 , H480347 , H489095 , H48A971 , H48C373 , H480349 , H489096 , H48A986 , H48C399 , H480353 , H489114 , H48A987 , H48C434 , H480354 , H489379 , H48B109 , H48C441 , H48D356 , H489417 , H48B138 , H48C442 , H48D394 , H489431 , H488216 , H48C443 , H48D397 , H489432 , H48B2S9 , H48C448 , H48DS17 , H489433 , H48B293 , H48C450 , H48DS24 , H489792 , H48B294 , H48C474 , H48D654 , H489793 , H48B295 , H48C475 , H48D688 , H489794 , H48B331 , H48C476 , H48D689 , H489819 , H48B332 , H48CSS7 , H48D690 , H489953 , H488333 , H48CSS8 , H480758 , H489996 , H48B334 , H48CSS9 , H48D956 , H48A029 , H48B399 , H48CS60 , H480957 , H48A083 , H48B471 , H48CS61 , H48D988 , H48A084 , H48B472 , H48CS75 , H48D992 , H48A085 , H48B480 , H48CS76 , H480993 , H48Al47 , H48BS86 , H48C661 , H48E031 , H48A148 , H48BS87 , H48C688 , H48E069 , H48A149 , H488588 , H48C689 , H48E106 , H48A150 , H48BS89 , H48C715 , H48El39 , H48A202 , H48B602 , H48C717 , H48E143 , H48A224 , H488605 , H48C795 , H48El52 , H48A225 , H488691 , H48C796 , H48El53 , H48A226 , H48B692 , H48C797 , H48E154 , H48A229 , H48B693 , H48C798 , H48El59 , H48A230 , H48B694 , H48C799 , H48E422 , H48A243 , H488787 , H48C800 , H48E423 , H48ES68 , H48F073 , H48FS17 , H48F927 , H48ES90 , H48F074 , H48FS18 , H48F939 , H48ES91 , H48F075 , H48FS19 , H48F944 , H48ES92 , H48F076 , H48FS23 , H48F948 , H48ES93 , H48F077 , H48FS24 , H48F980 , H48ES95 , H48F078 , H48FS34 , H48F993 , H48E609 , H48F079 , H48FS36 , H48F994 , H4BE677 , H48F083 , H4BF537 , H48G020 , H48EB16 , H48F084 , H48FS44 , H48G021 , H48E883 , H4BF085 , H48FS45 , H48G039 , H48E884 , H48F086 , H48FS46 , H48G041 , H48E885 , H48F089 , H48FS47 , H48G109 , H48E888 , H48F120 , H48FS48 , H48Gll7 , H48E890 , H48F131 , H48FS49 , H48G123 , H48E892 , H48F132 , H48FSSO , H48G153 , H48E893 , H48F134 , H48F568 , H48G154 , H48E894 , H48F135 , H48FS92 , H48Gl84 , H48E908 , H48F136 , H48F606 , H48G185 , H48E909 , H48F137 , H48F609 , H48G228 , H48E913 , H48F138 , H48F623 , H48G229 , H48E914 , H4BF156 , H48F624 , H48G230 , H48E915 , H48F166 , H48F637 , H48G235 , H48E916 , H48F167 , H4BF647 , H4BG236 , H4BE917 , H4BF168 , H4BF648 , H48G238 , H4BE918 , H4BF169 , H48F649 , H48G241 , H48E919 , H4BF170 , H48F697 , H48G242 , H48E920 , H48F184 , H48F698 , H48G246 , H48E921 , H48F185 , H48F713 , H48G247 , H4BE922 , H48F194 , H48F714 , H4BG249 , H4BE932 , H48F195 , H48F715 , H4BG250 , H4BE933 , H48F196 , H48F760 , H48G275 , H48E944 , H4BF197 , H48F761 , H48G276 , H48E945 , H48F199 , H48F777 , H48G277 , H4BE946 , H48F219 , H48F779 , H48G278 , H48E947 , H4BF268 , H48F780 , H48G279 , H48E948 , H48F312 , H48F791 , H4BG280 , H48E952 , H48F315 , H48F792 , H48G281 , H48E954 , H48F316 , H48F796 , H48G282 , H48E957 , H48F317 , H4BF824 , H48G283 , H4BE964 , H48F318 , H48FB25 , H48G284 , H48E966 , H4BF331 , H48F826 , H48G285 , H4BE989 , H4BF332 , H48F827 , H48G286 , H48E990 , H48F333 , H48F828 , H48G289 , H48E991 , H4BF354 , H48F829 , H48G290 , H48E992 , H48F394 , H48F835 , H4BG291 , H48E994 , H48F395 , H48F836 , H48G292 , H48E996 , H48F399 , H48F837 , H48G293 , H48F002 , H48F400 , H48F843 , H48G294 , H48F013 , H48F426 , H48F844 , H48G295 , H48F014 , H48F468 , H48FB45 , H48G296 , H48F016 , H48F469 , H48F852 , H48G363 , H4BF017 , H48F470 , H48F854 , H48G405 , H4BF018 , H48F490 , H48FBS6 , H48G413 , H48F025 , H48FS06 , H48F859 , H48G414 , H48F028 , H48FS07 , H48F865 , H48G487  , H481328 , H482681 , H484368 , H485893 , H487736 , H48A244 , H48B816 , H48C801 , H48E425 , H48F029 , H48FS08 , H48F922 , H483654 , H481329 , H482682 , H484435 , H485894 , H487737 , H48A245 , H48B818 , H48C802 , H48ES66 , H48FOS8 , H48FS09 , H48F925 , H48F393 , H481352 , H482732 , H484495 , H485895 , H487739 , H48A246 , H48B819 , H48C803 , H48ES67 , H48F072 , H48F516 , H48F926 , H482411 , H480974 , H48G246 , H480803 , H48B712 , H487089 , H482936 , H48A812 , H487040 , H48F730 , H48G585 , H486116 , H480875 , H482412 , H482384 , H48G247 , H481184 , H480536 , H481835 , H48F478 , H48F246 , H481005 , H48F731 , H48G586 , H48C095 , H480876 , H484904 , H487981 , H487466 , H48E426 , H48A712 , H481836 , H48F479 , H48F443 , H483856 , H48F733 , H48G587 , H48C096 , H48E762 , H48F345 , H487982 , H487782 , H48E427 , H480535 , H48B845 , H480323 , H48F444 , H48G405 , H48C540 , H48G588 , H48C097 , H48E763 , H483697 , H48B252 , H487798 , H48E441 , H484052 , H48F053 , H480324 , H481289 , H481828 , H48C541 , H48G589 , H48C098 , H48E764 , H48F765 , H48F338 , H48G414 , H48E514 , H48F615 , H480971 , H480325 , H481290 , H481829 , H484381 , H48G590 , H48C099 , H48F240 , H487773 , H48F352 , H481315 , H48E517 , H48F617 , H485963 , H486683 , H481291 , H481830 , H488320 , H48G591 , H48C100 , H48F241 , H48G267 , H48F353 , H481316 , H489872 , H48F724 , H482203 , H480262 , H481292 , H481831 , H487595 , H48G592 , H48C101 , H48F326 , H48F355 , H488452 , H481334 , H48F727 , H486934 , H48A254 , H481293 , H480873 , H48F833 , H48GS93 , H48C102 , H48F327 , H482935 , H48A911 , H481335 , H48F729 , H48B366 , H48G584 , H482201 , H480874 , H48F834 , H485100 , H48C103 , H483509 , H485125 , H48C104 , H482381 , H484280 , H480346 , H48A295 , H48B057 , H48G002 , H48E984 , H48F483 , H482383 , H48F942 , H487212 , H48C105 , H486701 , H482164 , H481510 , H48A296 , H48E537 , H48G004 , H48E985 , H48F484 , H483649 , H485896 , H480107 , H48F754 , H48E973 , H486370 , H482289 , H48A184 , H482196 , H48G006 , H48E986 , H483374 , H480830 , H481063 , H480920 , H48F755 , H48E974 , H483506 , H482807 , H480556 , H484018 , H48G007 , H48E987 , H483375 , H483615 , H48A395 , H482793 , H48F756 , H48E975 , H485400 , H487623 , H480557 , H484019 , H484624 , H48E988 , H483376 , H485821 , H48G198 , H480051 , H48F757 , H48E976 , H48B549 , H48E962 , H480558 , H484020 , H480933 , H48F790 , H487866 , H480004 , H481077 , H480052 , H48F758 , H486927 , H483964 , H48E977 , H486581 , H48F526 , H480934 , H48F186 , H487867 , H48F428 , H481078 , H480053 , H484497 , H480692 , H484903 , H48E978 , H48F054 , H480348 , H48F868 , H480530 , H488820 , H48F595 , H482263 , H480054 , H484498 , H480693 , H486069 , H48E979 , H48F059 , H480349 , H481837 , H480055 , H484499 , H488056 , H486071 , H48E980 , H487776 , H482382 , H481838

Radiology Devices

2

No

Worldwide Distribution - USA Nationwide

Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.

Software version and build numbers 2.0.0.15, 2.5.1.89, and 3.0.0.251 (to determine if the version used is affected, bring up the About box in the RayStation application and check the build number reported0.

Radiology Devices

2

No

Worldwide Distribution - USA including Connecticut, Florida, Massachusetts, Missouri, New York, Ohio, and foreign distribution to(Canada, Italy, Australia, Germany, Netherlands, and Switzerland.

RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. || RayStation is a software system designed for treatment planning and analysis of radiation therapy.

All versions of Monaco

Radiology Devices

2

No

Distributed in Puerto Rico and the states of AK, AZ, CA, CO, CT, FL, IL, IN, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, and WA.

Monaco RTP System Radiation Therapy Treatment Planning System. || Radiation treatment planning.