The following data is part of a premarket notification filed by Tomotherapy Incorporated with the FDA for Modification To Hi-art Treatment System.
| Device ID | K082005 |
| 510k Number | K082005 |
| Device Name: | MODIFICATION TO HI-ART TREATMENT SYSTEM |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | TOMOTHERAPY INCORPORATED 1209 DEMING WAY Madison, WI 53717 |
| Contact | Robert Bovy |
| Correspondent | Robert Bovy 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 | 2008-07-14 |
| Decision Date | 2008-08-25 |
| Summary: | summary |