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

• 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