TomoHD® Treatment Delivery System NA

GUDID 00811376030344

TomoTherapy Treatment System (H Series)

Accuray Incorporated

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