LogoFDA 510(k) Search
K Number
K072504
Device Name
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
Manufacturer
ACCURAY INCORPORATED
Date Cleared
2007-09-21

(15 days)

Product Code
IYE,TYE
Regulation Number
892.5050
Type
Special
Panel
RA
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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, Xsight" Lung Tracking, and Synchrony" Respiratory Tracking for dynamic positioning and pointing of the linear accelerator.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies with sample sizes, expert qualifications, or ground truth establishment. The document is a 510(k) summary and an FDA clearance letter for the CyberKnife® Robotic Radiosurgery System, primarily focusing on its intended use and substantial equivalence to a predicate device, rather than detailed performance study results.

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.