TomoHD® Treatment Delivery System NA

GUDID 00811376030344

TomoTherapy Treatment System (H Series)

Accuray Incorporated

Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system

• Primary Device ID: 00811376030344
• NIH Device Record Key: 9254e45e-7534-40e2-99f3-d31cfcc59d72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TomoHD® Treatment Delivery System
• Version Model Number: 1018283-000
• 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	00811376030344 [Primary]
HIBCC	M65810182830 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121934

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

• 00811376030795 - SW, Legal Labelling Install Disk, 5.1.9: 2023-12-29 TomoTherapy Treatment System (H Series)
• 00811376030344 - TomoHD® Treatment Delivery System: 2022-01-12TomoTherapy Treatment System (H Series)
• 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: 2022-01-12 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