The following data is part of a premarket notification filed by Tomotherapy Incorporated with the FDA for Modification To: Hi-art System.
| Device ID | K033347 |
| 510k Number | K033347 |
| Device Name: | MODIFICATION TO: HI-ART SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | TOMOTHERAPY INCORPORATED 1240 DEMING WAY Madison, WI 53717 |
| Contact | Kenneth D Buroker |
| Correspondent | Kenneth D Buroker TOMOTHERAPY INCORPORATED 1240 DEMING WAY Madison, WI 53717 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-20 |
| Decision Date | 2003-11-12 |
| Summary: | summary |