The following data is part of a premarket notification filed by Tomotherapy Incorporated with the FDA for Tomotherapy Treatment System.
| Device ID | K112446 |
| 510k Number | K112446 |
| Device Name: | TOMOTHERAPY TREATMENT SYSTEM |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | TOMOTHERAPY INCORPORATED 1209 DEMING WAY Madison, WI 53717 |
| Contact | Greg Bange |
| Correspondent | Greg Bange TOMOTHERAPY INCORPORATED 1209 DEMING WAY Madison, WI 53717 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-24 |
| Decision Date | 2011-10-07 |
| Summary: | summary |