The following data is part of a premarket notification filed by Tomo Therapy Inc with the FDA for Hi-art System.
| Device ID | K013673 |
| 510k Number | K013673 |
| Device Name: | HI-ART SYSTEM |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | TOMO THERAPY INC 2228 EVERGREEN RD. Middleton, WI |
| Contact | Kenneth D Buroker |
| Correspondent | Kenneth D Buroker TOMO THERAPY INC 2228 EVERGREEN RD. Middleton, WI |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-06 |
| Decision Date | 2002-01-28 |
| Summary: | summary |