TomoTherapy Incorporated

Serial Numbers: 110001 110040 110078 110118 110159 110197 110238 110002 110041 110079 110119 110160 110198 110239 110003 110042 110081 110120 110161 110199 110240 110004 110043 110082 110122 110162 110200 110241 110005 110044 110083 110123 110164 110201 110242 110006 110045 110084 110125 110165 110202 110243 110007 110046 110085 110126 110166 110203 110244 110008 110047 110086 110127 110167 110204 110245 110009 110048 110087 110128 110168 110205 110246 110012 110049 110088 110129 110169 110206 110247 110013 110050 110089 110130 110170 110207 110248 110014 110051 110090 110131 110171 110208 110249 110015 110052 110091 110132 110172 110209 110250 110016 110053 110092 110133 110173 110210 110251 110017 110054 110093 110134 110174 110211 110252 110018 110055 110094 110135 110175 110212 110253 110019 110056 110095 110136 110176 110213 110254 110020 110057 110096 110137 110177 110214 110255 110021 110058 110097 110138 110178 110215 110256 110022 110059 110098 110139 110179 110216 110257 110023 110060 110100 110140 110180 110217 110258 110024 110061 110101 110141 110181 110218 110259 110025 110062 110103 110142 110182 110219 110260 110026 110063 110104 110143 110183 110220 110262 110027 110064 110105 110144 110184 110221 110263 110028 110065 110106 110145 110185 110222 110264 110029 110066 110107 110146 110186 110223 110265 110030 110067 110108 110149 110187 110224 110266 110031 110068 110109 110150 110188 110225 110267 110032 110069 110110 110151 110189 110227 110268 110033 110071 110111 110152 110190 110228 110269 110034 110072 110112 110153 110191 110230 110272 110035 110073 110113 110154 110192 110233 110275 110036 110074 110114 110155 110193 110234 110276 110037 110075 110115 110156 110194 110235 110277 110038 110076 110116 110157 110195 110236 110280 110039 110077 110117 110158 110196 110237 and 110283.

Radiology Devices

2

No

Worldwide Distribution -- US (states of AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL IN, IA, KS, KY, LA, MD, MA, MI, MN,MO, NE,NV,NJ, NM, NY, OH, OK OR, PA, PR, SC, SC, TN, TX, UT, VA, WA, WI and WY) and Belgium Canada Switzerland China Germany Spain France England Hong Kong India Italy Japan Korea Netherlands Poland Saudi Arabia Sweden Singapore Turkey and Taiwan.

TomoTherapy Hi-Art System¿, Version 3.X || ThomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. || The TomoTherapy HI-ART System¿¿ is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.

Serial #'s: 110019. 110037, 110056, 110091, 110169, 110281.

Radiology Devices

2

No

Worldwide Distribution -- MI, MO, VA, and WI and country of CANADA.

TomoTherapy Hi-Art System¿, Version 4.0.0 & 4.0.1. || TomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. || Intended to be used as an integrated system for planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.

Serial #'s:  110019, 110083, 110169, 110284, 110305, 110312, 110034, 110091, 110174, 110285, 110306, 110314, 110037, 110092, 110278, 110288, 110308, 110316, 110056, 110150, 110281, 110293, 110309, 110318, 110065, 110159, 110283, 110300, 110311

Radiology Devices

2

No

CA, CO, IL, LA, MI, MO, NY, ND, OH, OK, PA,VA, WI, BELGIUM CANADA, KOREA, MALAYSIA, SWITZERLAND, ITALY, GREAT BRITAIN, FRANCE.

TomoTherapy Hi-Art System¿, ver. 4.0.0, 4.0.1, 4.0.2, ThomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. The TomoTherapy HI-ART System¿ is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.

110019

Radiology Devices

2

No

VA

Hi-Art System, H-0000-0003 || Usage: The TomoTherapy Hi-Art System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan

Serial #'s  110019 110254 110299 110327 110024 110271 110300 110328 110051 110277 110303 110329 110056 110278 110308 110330 110091 110281 110309 110332 110092 110283 110310 110333 110174 110284 110311 110335 110202 110285 110313 110336 110243 110288 110318 110337 110251 110293 110326, and 110339.

Radiology Devices

2

No

Worldwide Distribution -- USA, including the states of AZ, CO, IL, KS, MI, MO, NV, NY, ND, OH, OK PA, UT, and VA and countries of MALAYSIA, SWITZERLAND, KOREA, ITALY, SPAIN, CANDA, TAIWAN, JAPAN, BELGIUM

ThomoTherapy Hi-Art System || Intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.