CyberKnife® VSI™ Robotic Radiosurgery System Japan NA

GUDID 00811376030429

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: 00811376030429
• NIH Device Record Key: dc234f9a-c713-460b-b944-3fc14bad6055
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CyberKnife® VSI™ Robotic Radiosurgery System Japan
• Version Model Number: 032500-M-000
• Catalog Number: NA
• Company DUNS: 080044624
• 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: 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	00811376030429 [Primary]
HIBCC	M6580325000 [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

Devices Manufactured by Accuray Incorporated

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• 00811376030344 - TomoHD® Treatment Delivery System: 2022-01-12 TomoTherapy Treatment System (H Series)
• 00811376030368 - CyberKnife® VSI™ Robotic Radiosurgery System: 2022-01-12 The CyberKnife® Treatment Delivery System (CKTDS) is a computer-controlled radiation treatment delivery system for performing m
• 00811376030429 - CyberKnife® VSI™ Robotic Radiosurgery System Japan: 2022-01-12The 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.
• 00811376030429 - CyberKnife® VSI™ Robotic Radiosurgery System Japan: 2022-01-12 The CyberKnife® Treatment Delivery System (CKTDS) is a computer-controlled radiation treatment delivery system for performing m
• 00811376030436 - CyberKnife® M6™ Systems: 2022-01-12 CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM) The CyberKnife M6 Systems are computer-c
• 00811376030443 - CyberKnife® M6™ Systems: 2022-01-12 CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM) The CyberKnife M6 Systems are computer-c
• 00811376030450 - CyberKnife® M6™ Systems: 2022-01-12 CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM) The CyberKnife M6 Systems are computer-c
• 00811376030467 - CyberKnife® M6™ Systems: 2022-01-12 CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM) The CyberKnife M6 Systems are computer-c