Radixact™ Treatment Delivery System N/A
GUDID M65810600000
Radixact Treatment Delivery System
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 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 Linear accelerator system Linear accelerator system Linear accelerator system| Primary Device ID | M65810600000 |
| NIH Device Record Key | c0e29cdd-62bd-4334-9488-5a311877b298 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Radixact™ Treatment Delivery System |
| Version Model Number | 1060000 |
| Catalog Number | N/A |
| Company DUNS | 785961244 |
| 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 | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com | |
| Phone | 4087164600 |
| webhelp@accuray.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811376030009 [Primary] |
| HIBCC | M65810600000 [Previous] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K161146
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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-01-26 |
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 | 2022-01-12 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 |
Trademark Results [Radixact]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RADIXACT 86742946 5092439 Live/Registered |
Accuray Incorporated 2015-08-31 |
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