The following data is part of a premarket notification filed by Helax Ab with the FDA for Helax-tms V 5.0 Radiation Therapy Treatment Planning System.
| Device ID | K993766 |
| 510k Number | K993766 |
| Device Name: | HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | HELAX AB 447 MARCH ROAD Kanata Ontario, CA K2k 1x8 |
| Contact | E.s. Martell |
| Correspondent | E.s. Martell HELAX AB 447 MARCH ROAD Kanata Ontario, CA K2k 1x8 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-08 |
| Decision Date | 1999-12-08 |
| Summary: | summary |