TomoHDA® Treatment Delivery System NA

GUDID M65810182860

TomoTherapy Treatment System (H Series)

Accuray Incorporated

Linear accelerator system

• Primary Device ID: M65810182860
• NIH Device Record Key: 5af6ee70-357e-400a-b028-439265e63188
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TomoHDA® Treatment Delivery System
• Version Model Number: 1018286-000
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M65810182860 [Primary]

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-08-20
• Device Publish Date: 2016-09-22

On-Brand Devices [TomoHDA® Treatment Delivery System]

• M65810182860: TomoTherapy Treatment System (H Series)
• 00811376030481: TomoTherapy Treatment System (H Series)