The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon.
| Device ID | K173789 |
| 510k Number | K173789 |
| Device Name: | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon |
| Classification | System, Radiation Therapy, Radionuclide |
| Applicant | Elekta Instrument AB Kungstensgatan 18 Stockholm, SE 10393 |
| Contact | Alf Laurell |
| Correspondent | Alf Laurell Elekta Instrument AB Kungstensgatan 18 Stockholm, SE 10393 |
| Product Code | IWB |
| CFR Regulation Number | 892.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-14 |
| Decision Date | 2018-03-30 |
| Summary: | summary |