Devices

CyberKnife Robotic Radiosurgery System with IRIS Variable Aperture Collimator.

Model / Serial
Catalog/Part number 054000-0001; Serial numbers: C0141 C0182 C0225 C0256 C0137 C0112 C0244 C0210 C0160 C0208 C0118 C0090 C0207 C0181 C0034 C0047 C0197 C0174 C0101 C0186 C0178 Serial # C0198 C0214 C0059 C0172 C0068 C0057 C0263 C0092 C0199 C0151 C0179 C0226 C0158 C0131 C0144 C0223 C0071 C0094 C0183 C0143 Serial # C0192 C0055 C0072 C0061 C0134 C0177 C0247 International Sites Serial # C0175 C0189 C0191 C0215 C0227 C0187 C0242 C0185 C0218 C0237 C0240 C0265 C0268 C0251 C0235 C0229 C0212 C0239 Serial # C0043 C0211 C0255 C0270 C0176 C0093 C0234 C0221 C0249 C0232 C0180 C0238 C0231 C0202 C0230 C0264 C0266.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA including CA, MS, FL, AZ, DC, TX, CO, CT, IL, WI, RI, NV, OK, MA, AL, NY, MO, NC, TN, PA, DE, NJ, MI, IN, KS, OH. Foreign distribution to Turkey, Switzerland, Spain, Saudi Arabia, Russia, Poland, Mexico and Korea, Italy, India, Greece, Germany, France, England, Canada, and Belgium.
Product Description
CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. || The CyberKnife is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Manufacturer
Accuray Incorporated
1 Event
- Recall of CyberKnife Robotic Radiosurgery System with IRIS Variable Aperture Collimator.

Manufacturer

Accuray Incorporated

Manufacturer Address
Accuray Incorporated, 1310 Chesapeake Ter, Sunnyvale CA 94089-1100
Manufacturer Parent Company (2017)
Accuray Inc
Source
USFDA

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