Accuray Precision Treatment Planning System NA

GUDID 00811376030092

Accuray Precision™ Treatment Planning System (Version 3.0)

ACCURAY INCORPORATED

Radiation therapy treatment planning workstation Radiation therapy treatment planning workstation Radiation therapy treatment planning workstation Radiation therapy treatment planning workstation Radiation therapy treatment planning workstation Radiation therapy treatment planning workstation Radiation therapy treatment planning workstation Radiation therapy treatment planning workstation Radiation therapy treatment planning workstation Radiation therapy treatment planning workstation Radiation therapy treatment planning workstation Radiation therapy treatment planning workstation Radiation therapy treatment planning workstation Radiation therapy treatment planning workstation Radiation therapy treatment planning workstation Radiation therapy treatment planning workstation

• Primary Device ID: 00811376030092
• NIH Device Record Key: 1be0faee-0551-43ad-8024-5a3e3222fc35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accuray Precision Treatment Planning System
• Version Model Number: 1063143
• 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
• 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	00811376030092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171086

FDA Product Code

• MUJ: System, Planning, Radiation Therapy Treatment

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: 2019-06-10
• Device Publish Date: 2019-05-31

On-Brand Devices [Accuray Precision Treatment Planning System]

• 00811376030092: Accuray Precision™ Treatment Planning System (Version 3.0)
• 00811376030146: Accuray Precision™ Treatment Planning System (Version 3.1)