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Software, Version 2.0, iDMS Data Management System
The iDMS Data Management System is indicated for the storage, retrieval, and processing of data utilized in the practice of radiotherapy, stereotactic radiotherapy and stereotactic radiosurgery.
ACCURAY INCORPORATED
1061513
In Commercial Distribution
- M65810615130 ()
NA
- Patient health record information system application software
Software, TomoApps, Version 5.1.2
Operating Software for TomoTherapy systems (including TomoH®, TomoHD®, TomoHDA) and Onrad Treatment System™
ACCURAY INCORPORATED
1060464
In Commercial Distribution
- M65810604640 ()
NA
- Linear accelerator system
Radixact Delivery System Software (Version 1.1)
ACCURAY INCORPORATED
1060253
In Commercial Distribution
- M65810602530 ()
N/A
- Linear accelerator system
The Radixact Treatment Delivery System is a radiation therapy delivery system that provides Image Guided Radiation Therapy (IGRT) using integral megavoltage CT
imaging capabilities and delivers helical (rotational) and fixed-angle (non-rotational) radiation therapy to tumors and other targeted tissues.
The Radixact Treatment Delivery System is a prescription device that delivers radiation in accordance with a physician approved plan. The Radixact Treatment Delivery System does not diagnose disease, recommend treatment regimens or quantify treatment effectiveness. It is not intended for diagnostic use.
ACCURAY INCORPORATED
1060000
In Commercial Distribution
- M65810600000 ()
NA
- Linear accelerator system
Software, Version 1.0.0.1, Accuray Precision Treatment Planning System,
The Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.
ACCURAY INCORPORATED
1055096
In Commercial Distribution
- M65810550960 ()
NA
- Linear accelerator system
- Radiation therapy treatment planning computer
Software, Delivery Analysis, Version 1.1
ACCURAY INCORPORATED
1052591
In Commercial Distribution
- M65810525910 ()
NA
- Linear accelerator system
Software, Version 1.0.0.1, Treatment Delivery Console (TDC), Radixact
(Operating Software for Radixact® Treatment Delivery System)
ACCURAY INCORPORATED
1050241
In Commercial Distribution
- M65810502410 ()
NA
- Linear accelerator system
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