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The Onrad™ Treatment System is a radiation therapy system that integrates planning, dose
calculation, megavoltage CT imaging for IGRT functionality, and fixed beam (non-rotational)
radiation therapy treatment capabilities into a single comprehensive system.
The Onrad™ Treatment System is a prescription device. It delivers radiation in accordance
with a physician approved plan. The device does not diagnose disease, recommend treatment
regimens, or quantify treatment effectiveness. The megavoltage CT imaging functionality is
not intended for diagnostic use.
ACCURAY INCORPORATED
1049211
Not in Commercial Distribution
- M65810492110 ()
NA
- Linear accelerator system
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.
ACCURAY INCORPORATED
1047641-000
In Commercial Distribution
- M65810476410 ()
NA
- Linear accelerator system
TomoTherapy Treatment System (Tomo HD™)
ACCURAY INCORPORATED
H-0000-0003
In Commercial Distribution
- M6581043090 ()
NA
- Linear accelerator system
TomoTherapy® Treatment System (H Series)
ACCURAY INCORPORATED
1018284-000
In Commercial Distribution
- M65810182840 ()
NA
- Linear accelerator system
TomoTherapy Treatment System (H Series)
ACCURAY INCORPORATED
1018283-000
In Commercial Distribution
- M65810182830 ()
NA
- Linear accelerator system
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.
ACCURAY INCORPORATED
0660000
In Commercial Distribution
- M65806600000 ()
NA
- Linear accelerator system
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.
ACCURAY INCORPORATED
032500-M-000
In Commercial Distribution
- M6580325000 ()
NA
- Linear accelerator system
Scaler
ACME ENTERPRISE.
63001
Not in Commercial Distribution
- G149630010 ()
63001
- Manual dental scaler, reusable
No Description
ACTIVE BRANDS NORTH AMERICA INC
852059230000OS
In Commercial Distribution
- B910852059230000OS0 ()
- Tinted non-prescription spectacle lens
No Description
ACTIVE BRANDS NORTH AMERICA INC
852053220000OS
In Commercial Distribution
- B910852058230000OS0 ()
- Tinted non-prescription spectacle lens