The following data is part of a premarket notification filed by Helax Ab with the FDA for Helax-imcon, Version 1.0.
| Device ID | K982857 |
| 510k Number | K982857 |
| Device Name: | HELAX-IMCON, VERSION 1.0 |
| Classification | System, Simulation, Radiation Therapy |
| Applicant | HELAX AB KLOSTERGATAN 10-12 Uppsala, SE |
| Contact | Jan Tornqvist |
| Correspondent | Jan Tornqvist HELAX AB KLOSTERGATAN 10-12 Uppsala, SE |
| Product Code | KPQ |
| CFR Regulation Number | 892.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-13 |
| Decision Date | 1998-11-04 |
| Summary: | summary |