Address:1310 CHESAPEAKE TERRACE,Sunnyvale,CA,94089,US
Device Description : Software, CyberKnife Version 11.1 (Software group that operates CyberKnife Treat Software, CyberKnife Version 11.1 (Software group that operates CyberKnife Treatment Delivery System)
Device Class : 2
Duns Number: 785961244
Premarket Exempt : No
Prescription Use : Yes
Device Description : IDMS Data Management System (Version 3.0)
Device Class : 2
Duns Number: 785961244
Premarket Exempt : No
Prescription Use : Yes
Device Description : The CyberKnife VSI System is a computer controlled medical systems for planning The CyberKnife VSI System is a computer controlled medical systems for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy using a treatment radiation generator, linear accelerator, manipulator (robot), and a target locating subsystem to accurately deliver radiation to the treatment target. The target locating system provides X-rays of the treatment area taken by a diagnostic X-ray system that lets the user know the position of the target. The CyberKnife VSI Systems use skull tracking, fiducial tracking, Xsight® Spine Tracking, Xsight® Lung Tracking, and Synchrony® Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The system uses a 6 MV linear accelerator to provide a dose rate up to 1000 MU/minute.
Device Class : 2
Duns Number: 785961244
Premarket Exempt : No
Prescription Use : Yes
Device Description : The CyberKnife VSI System is a computer controlled medical systems for planning The CyberKnife VSI System is a computer controlled medical systems for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy using a treatment radiation generator, linear accelerator, manipulator (robot), and a target locating subsystem to accurately deliver radiation to the treatment target. The target locating system provides X-rays of the treatment area taken by a diagnostic X-ray system that lets the user know the position of the target. The CyberKnife VSI Systems use skull tracking, fiducial tracking, Xsight® Spine Tracking, Xsight® Lung Tracking, and Synchrony® Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The system uses a 6 MV linear accelerator to provide a dose rate up to 1000 MU/minute.
Device Class : 2
Duns Number: 785961244
Premarket Exempt : No
Prescription Use : Yes
Device Description : The CyberKnife® Treatment Delivery System (CKTDS) is a computer-controlled radia The CyberKnife® Treatment Delivery System (CKTDS) is a computer-controlled radiation treatment delivery system for performing minimally invasive stereotactic radiosurgery and precision radiotherapy. The CyberKnife Treatment Delivery System is intended to work with Accuray Precision® Treatment Planning System and iDMS™ Data Management System.
Device Class : 2
Duns Number: 785961244
Premarket Exempt : No
Prescription Use : Yes
Device Description : TomoTherapy Treatment System (H Series)
Device Class : 2
Duns Number: 785961244
Premarket Exempt : No
Prescription Use : Yes
Device Description : TomoTherapy® Treatment System (H Series)
Device Class : 2
Duns Number: 785961244
Premarket Exempt : No
Prescription Use : Yes
Device Description : TomoTherapy Treatment System (Tomo HD™)
Device Class : 2
Duns Number: 785961244
Premarket Exempt : No
Prescription Use : Yes
Device Description : TomoTherapy Treatment System (re-new system)
Device Class : 2
Duns Number: 785961244
Premarket Exempt : No
Prescription Use : Yes
Device Description : CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM)The CyberKnife M6 Systems are computer-controlled medical systems for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy. They use a 6 MV linear accelerator mounted on a manipulator (robot) and a target locating subsystem to accurately deliver high-energy radiation (1000 MU/minute dose rate) to the treatment target. The target locating subsystem provides X-rays of the treatment area that lets the user know the position of the target.The CyberKnife M6 Systems use skull tracking, fiducial tracking (tracking of implanted radiographic markers), skeletal structure tracking, lung tumor tracking, Lung Optimized Treatment, and Synchrony Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The fixed, variable aperture and multileaf collimators are available as various beam-limiting secondary collimators.
Device Class : 2
Duns Number: 785961244
Premarket Exempt : No
Prescription Use : Yes