| 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 |
| Phone | 408-716-4600 |
| webhelp@accuray.com | |
| Phone | 408-716-4600 |
| webhelp@accuray.com | |
| Phone | 408-716-4600 |
| webhelp@accuray.com | |
| Phone | 408-716-4600 |
| webhelp@accuray.com | |
| Phone | 408-716-4600 |
| webhelp@accuray.com | |
| Phone | 408-716-4600 |
| webhelp@accuray.com | |
| Phone | 408-716-4600 |
| webhelp@accuray.com | |
| Phone | 408-716-4600 |
| webhelp@accuray.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M65810182860 [Primary] |
| IYE | Accelerator, Linear, Medical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-08-20 |
| Device Publish Date | 2016-09-22 |
| M65810182860 | TomoTherapy Treatment System (H Series) |
| 00811376030481 | TomoTherapy Treatment System (H Series) |