The following data is part of a premarket notification filed by Helax Ab with the FDA for Helax-visir.
| Device ID | K972617 |
| 510k Number | K972617 |
| Device Name: | HELAX-VISIR |
| Classification | Accelerator, Linear, Medical |
| Applicant | HELAX AB KLOSTERG. 12 Uppsala, SE S-75147 |
| Contact | Jan Tornqvist |
| Correspondent | Jan Tornqvist HELAX AB KLOSTERG. 12 Uppsala, SE S-75147 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-09 |
| Decision Date | 1997-10-01 |
| Summary: | summary |