CyberKnife® Treatment Delivery System NA

GUDID 00811376030023

Software, CyberKnife Version 11.1 (Software group that operates CyberKnife Treatment Delivery System)

ACCURAY INCORPORATED

Linear accelerator system

• Primary Device ID: 00811376030023
• NIH Device Record Key: 2f8498ee-1094-4fcc-b285-5d8474987c1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CyberKnife® Treatment Delivery System
• Version Model Number: 1061945
• Catalog Number: NA
• Company DUNS: 785961244
• Company Name: ACCURAY INCORPORATED
• Device Count: 1
• DM Exempt: false
• 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: false
• Manufacturing Date: false
• 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: 408-716-4600
• Email: webhelp@accuray.com
• Phone: 408-716-4600
• Email: webhelp@accuray.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811376030023 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-27

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