CyberKnife® M6™ Systems NA

GUDID 00811376030467

CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM) The CyberKnife M6 Systems are computer-controlled medical systems for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy. They use a 6 MV linear accelerator mounted on a manipulator (robot) and a target locating subsystem to accurately deliver high-energy radiation (1000 MU/minute dose rate) to the treatment target. The target locating subsystem provides X-rays of the treatment area that lets the user know the position of the target. The CyberKnife M6 Systems use skull tracking, fiducial tracking (tracking of implanted radiographic markers), skeletal structure tracking, lung tumor tracking, Lung Optimized Treatment, and Synchrony Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The fixed, variable aperture and multileaf collimators are available as various beam-limiting secondary collimators.

Accuray Incorporated

Linear accelerator system

• Primary Device ID: 00811376030467
• NIH Device Record Key: 61c8cec5-69ff-48dd-ac3b-12626226ffec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CyberKnife® M6™ Systems
• Version Model Number: 053401-M-000
• Catalog Number: NA
• Company DUNS: 080044624
• 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: 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: 408-716-4600
• Email: webhelp@accuray.com
• Phone: 408-716-4600
• Email: webhelp@accuray.com
• Phone: 408-716-4600
• Email: webhelp@accuray.com
• Phone: 408-716-4600
• Email: webhelp@accuray.com
• Phone: 408-716-4600
• Email: webhelp@accuray.com
• Phone: 408-716-4600
• Email: webhelp@accuray.com
• Phone: 408-716-4600
• Email: webhelp@accuray.com
• Phone: 408-716-4600
• Email: webhelp@accuray.com
• Phone: 408-716-4600
• Email: webhelp@accuray.com
• Phone: 408-716-4600
• Email: webhelp@accuray.com
• Phone: 408-716-4600
• Email: webhelp@accuray.com
• Phone: 408-716-4600
• Email: webhelp@accuray.com
• Phone: 408-716-4600
• Email: webhelp@accuray.com
• Phone: 408-716-4600
• Email: webhelp@accuray.com
• Phone: 408-716-4600
• Email: webhelp@accuray.com
• Phone: 408-716-4600
• Email: webhelp@accuray.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811376030467 [Primary]
HIBCC	M6580534010 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122137

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: 1
• Public Version Date: 2022-01-12
• Device Publish Date: 2022-01-04

On-Brand Devices [CyberKnife® M6™ Systems]

• M6580533010: CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM) The Cybe
• M6580532010: CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM) The Cybe
• M6580531010: CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM) The Cybe
• 00811376030498: CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM) The Cybe
• 00811376030467: CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM) The Cybe
• 00811376030450: CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM) The Cybe
• 00811376030443: CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM) The Cybe
• 00811376030436: CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM) The Cybe