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Found 10 results
510(k) Data Aggregation
K Number
K091999Device Name
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
Manufacturer
ACCURAY, INC.
Date Cleared
2009-09-18
(78 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
ACCURAY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CyberKnife VSI™ Robotic Radiosurgery System is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions anywhere in the body when radiation treatment is indicated.
Device Description
The CyberKnife VSI Robotic Radiosurgery System is a computer controlled medical system 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 CyberKnife VSI uses skull tracking, fiducial tracking, Xsight® Spine Tracking, Xsight® Lung Tracking, and Synchrony® Respiratory Tracking for dynamic positioning and pointing of the linear accelerator.
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K Number
K091146Device Name
MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
Manufacturer
ACCURAY, INC.
Date Cleared
2009-05-01
(11 days)
Product Code
MUJ
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
ACCURAY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CyberKnife® Robotic Radiosurgery System is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions anywhere in the body when radiation treatment is indicated.
Device Description
The CyberKnife Robotic Radiosurgery System is a computer controlled medical system 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 CyberKnife System uses skull tracking, fiducial tracking, Xsight™ Spine Tracking, Xsight" Lung Tracking, and Synchrony" Respiratory Tracking for dynamic positioning and pointing of the linear accelerator.
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K Number
K062967Device Name
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
Manufacturer
ACCURAY, INC.
Date Cleared
2006-10-30
(31 days)
Product Code
MUJ
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
ACCURAY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CyberKnife® Robotic Radiosurgery System is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions anywhere in the body when radiation treatment is indicated.
The CyberKnife® Robotic Radiosurgery System 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.
Device Description
The CyberKnife Robotic Radiosurgery System is a computer controlled medical system 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 CyberKnife System uses skull tracking, fiducial tracking, Xsight™ spine tracking, Synchrony" Respiratory Tracking and Lung Tumor Tracking for dynamic positioning and pointing of the linear accelerator.
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K Number
K051941Device Name
CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM
Manufacturer
ACCURAY, INC.
Date Cleared
2005-08-09
(22 days)
Product Code
MUJ
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
ACCURAY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CyberKnife System for Stereotactic Radiosurgery/Radiotherapy is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for lesions, turnors and conditions anywhere in the body when radiation treatment is indicated.
Device Description
The CyberKnife System is a computer-controlled medical system 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 anywhere in the body.
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K Number
K041315Device Name
CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
Manufacturer
ACCURAY, INC.
Date Cleared
2004-06-10
(24 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
ACCURAY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CyberKnife System for Stereotactic Radiosurgery/Radiotherapy is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Device Description
The CyberKnife System is a computer controlled medical system 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 CyberKnife System uses skull tracking, fiducial tracking and skeletal structure tracking for dynamic positioning and pointing of the linear accelerator.
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K Number
K032345Device Name
CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY
Manufacturer
ACCURAY, INC.
Date Cleared
2003-09-03
(35 days)
Product Code
MUJ
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
ACCURAY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CyberKnife System for Stereotactic Radiosurgery/Radiotherapy is intended to provide treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Device Description
The CyberKnife System is a computer controlled medical system for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy using a treatment radiation generator, linear accelerator, manipulator (robot), and a sophisticated target locating subsystem to accurately deliver radiation to the treatment target. The CyberKnife System uses skull tracking and tracking of implanted fiducials for dynamic positioning and pointing of the linear accelerator.
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K Number
K020294Device Name
MOTION TRACKING
Manufacturer
ACCURAY, INC.
Date Cleared
2002-04-22
(84 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
ACCURAY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To provide an option to the CyberKnife System which will enable dynamic image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions that move under the influence of respiration.
Device Description
Presently, irradiation of lesions that move during breathing, such as those located in the lung or near the diaphragm, would typically be performed during patient breath-holds. The Motion Tracking System option to the CyberKnife® System is designed to treat lesions while they are moving during the respiratory cycle. This offers the ability to reduce normal tissue exposure by using smaller irradiation margins, shorten treatments, increase accuracy and provide more comfort for the patient.
During motion tracking operation, a correspondence between surface (e.g. thorax/abdomen) movements and movement of the target lesion is developed prior to the start of treatment and is regularly updated during treatment each time the CyberKnife system acquires a new pair of x-ray images. This correspondence is then used to estimate lesion position in real time by monitoring surface movement during treatment.
Motion Tracking provides the CyberKnife system with the capability to monitor the patient's respiration and command the robot manipulator to compensate for the treatment target motion within the body, in real-time, while the radiation is being delivered.
The Motion Tracking System includes a sensor assembly, tracking targets, a cable junction box, and a controller.
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K Number
K011024Device Name
CYBERKNIFE SYSTEM
Manufacturer
ACCURAY, INC.
Date Cleared
2001-08-10
(128 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
ACCURAY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000478Device Name
THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1
Manufacturer
ACCURAY, INC.
Date Cleared
2000-04-19
(65 days)
Product Code
IWB
Regulation Number
892.5750Why did this record match?
Applicant Name (Manufacturer) :
ACCURAY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K984563Device Name
THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
Manufacturer
ACCURAY, INC.
Date Cleared
1999-07-14
(203 days)
Product Code
IWB
Regulation Number
892.5750Why did this record match?
Applicant Name (Manufacturer) :
ACCURAY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for lesions (e.g. arteriovenous malformations), tumors and conditions of the brain, base of skull (BOS), cervico-thoracic spine (CTS), head and neck.
Device Description
The CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy is a treatment planning, imaging, and treatment delivery system for image-guided stereotactic radiosurgery and precision radiotherapy. The treatment planning system provides 3-dimensional viewing of the patient anatomy with appropriate dose calculation of the target volume and surrounding tissue structures. The imaging system provides real-time, orthogonal x-ray images of the patient in the treatment position to verify treatment position and accuracy and provides information suitable for dynamically positioning and pointing a linear accelerator. The treatment delivery system consists of a linear accelerator which provides 6 MV x-rays. A six-access manipulator provides automated positioning and pointing of the linear accelerator. The treatment couch provides positioning of the patient.
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