CyberKnife® Treatment Delivery System N/A

GUDID M65806600000

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

Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system

• Primary Device ID: M65806600000
• NIH Device Record Key: 8c6df551-06c9-4e8f-9187-7069759ab5d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CyberKnife® Treatment Delivery System
• Version Model Number: 0660000
• Catalog Number: N/A
• Company DUNS: 785961244
• Company Name: ACCURAY INCORPORATED
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 4087164600
• Email: webhelp@accuray.com
• Phone: 4087164600
• Email: webhelp@accuray.com
• Phone: 4087164600
• Email: webhelp@accuray.com
• Phone: 4087164600
• Email: webhelp@accuray.com
• Phone: 4087164600
• Email: webhelp@accuray.com
• Phone: 4087164600
• Email: webhelp@accuray.com
• Phone: 4087164600
• Email: webhelp@accuray.com
• Phone: 4087164600
• Email: webhelp@accuray.com
• Phone: 4087164600
• Email: webhelp@accuray.com
• Phone: 4087164600
• Email: webhelp@accuray.com
• Phone: 4087164600
• Email: webhelp@accuray.com
• Phone: 4087164600
• Email: webhelp@accuray.com
• Phone: 4087164600
• Email: webhelp@accuray.com
• Phone: 4087164600
• Email: webhelp@accuray.com
• Phone: 4087164600
• Email: webhelp@accuray.com
• Phone: 4087164600
• Email: webhelp@accuray.com
• Phone: 4087164600
• Email: webhelp@accuray.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811376030016 [Primary]
HIBCC	M65806600000 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170788

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-26

On-Brand Devices [CyberKnife® Treatment Delivery System]

• 00811376030023: Software, CyberKnife Version 11.1 (Software group that operates CyberKnife Treatment Delivery Sy
• M65806600000: The CyberKnife® Treatment Delivery System (CKTDS) is a computer-controlled radiation treatment