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 |