Devices

Radiation Therapy System

  • Model / Serial
    USA 110001 110002 110003 110004 110005 110006 110007 110008 110012 110015 110016 110019 110020 110021 110023 110026 110027 110028 110029 110030 110031 110032 110033 110035 110038 110040 110042 110043 110044 110045 110047 110048 110050 110051 110053 110054 110056 110057 110059 110060 110067 110073 110074 110082 110084 110086 110087 110089 110090 110092 110094 110095 110096 110097 110098 110103 110105 110106 110108 110112 110115 110116 110118 110119 110120 110122 110127 110132 110134 110135 110138 110139 110149 110152 110153 110154 110155 110158 110160 110161 110165 110166 110168 110173 110174 110175 110176 110177 110179 110180 110181 110185 110186 110187 110188 110190 110192 110193 110195 110196 110197 110198 110201 110202 110203 110204 110206 110209 110210 110213 110215 110216 110217 110221 110222 110223 110224 110225 110227 110242 and 110250  OUS 110034 110062 110083 110126 110140 110014 110037 110072 110130 110169 110137 110077 110111 110117 110123 110146 110151 110189 110114 110131 110143 110170 110061 110167 110228 110157 110018 110071 110136 110162 110171 110211 110199 110150 110178 110237 110068 110078 110194 110069 110110 110191 110207 and 110240
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AK AL AR AZ CA CO CT DC FL HI IA IL IN KY LA MA MD MI MN MO NE NJ NM NV NY OH OK OR PA PR SC SD TN TX VA WA WI and WY Belgium Canada Switzerland Germany Spain France Great Britain India Italy Japan Korea Netherlands Turkey and Taiwan
  • Product Description
    TomoTherapy HI-ART Systems with 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal. The product is intended for use in radiation therapy.
  • Manufacturer
    TomoTherapy Incorporated
  • 1 Event

Manufacturer

TomoTherapy Incorporated
  • Manufacturer Address
    TomoTherapy Incorporated, 1240 Deming Way, Madison WI 53717
  • Manufacturer Parent Company (2017)
    Accuray Inc
  • Source
    USFDA

10 devices with a similar name

Learn more about the data here

Device Recall ViewRay Radiation Therapy System
  • Model / Serial
    M/N 10000, S/N 100 only
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US distribution to MO.
  • Product Description
    ViewRay System, Radiation Therapy System
  • Manufacturer
    Viewray Incorporated
Device Recall MRIdian ViewRay Radiation Therapy System, ViewRay
  • Model / Serial
    Catalog/Part Number: 10000; Serial Numbers: 100, 101, 102, & 105
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : CA, MO and WI., and Internationally to Korea.
  • Product Description
    MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ || Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
  • Manufacturer
    Viewray Incorporated
Device Recall Radionuclie radiation therapy system
  • Model / Serial
    4339, 4349, 5026, 4326, 5034, 4346, 4158, 4307, 4337, 4327, 4340, 5023, 5035, 5036, 4329, 4306, 4365, 4357, 5022, 4363, 4354, 4302, 4333, 4309, 4366, 4351, 4342, 4315, 4352, 4353, 4328, 5000, 4314, 4338, 4303, 4207, 4332, 4322, 4343, 4321, 4334, 4358
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (USA) - including the states of: CA, CO, DAL, FL, GA, IL, MD, MA, MI, MN, MO, NE, NV, NJ, NY, NC, OH, OK, OR, PA, TN, TX, VA, WA, WI and Puerto Rico
  • Product Description
    Elekta Leksell Gamma Knife C 1.2, 4 and 4C || Product Usage: Leksell Gamma Knife is a teletherapy device intended for stereotactic irradiation of head structures.
  • Manufacturer
    Elekta, Inc.
VARIS RADIATION THERAPY SYSTEM
  • Model / Serial
    Model Catalog: (Lot serial: SERIAL # 984 1098 1131 9045); Model Catalog: (Lot serial: SERIAL #746 751 873 907); Model Catalog: (Lot serial: 44); Model Catalog: (Lot serial: SERIAL #315); Model Catalog: (Lot serial: 260); Model Catalog: (Lot serial: SERIAL #495)
  • Product Description
    varis radiation therapy system
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.
Device Recall Radionuclide Radiation Therapy System
  • Model / Serial
    Serial Numbers: 6004-6006, 6009-6012, 6014-6018, 6020-6023, 6025, 6027 and 6029-6032.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- AR, AZ, CA, FLA, IL, MI, MN, MO, MS, NJ, OH, OR, PA, UT and VA.
  • Product Description
    Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. || Indicated for use in the stereotactic irradiation of intracranial structures.
  • Manufacturer
    Elekta, Inc.
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