The following data is part of a premarket notification filed by Accuray Incorporated with the FDA for Tomotherapy Treatment System.
| Device ID | K121934 |
| 510k Number | K121934 |
| Device Name: | TOMOTHERAPY TREATMENT SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | ACCURAY INCORPORATED 1209 DEMING WAY Madison, WI 53717 |
| Contact | Greg Bange |
| Correspondent | Greg Bange ACCURAY INCORPORATED 1209 DEMING WAY Madison, WI 53717 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-02 |
| Decision Date | 2012-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811376030351 | K121934 | 000 |
| 00811376030481 | K121934 | 000 |
| 00811376030474 | K121934 | 000 |
| 00811376030344 | K121934 | 000 |
| 00811376030795 | K121934 | 000 |