The following data is part of a premarket notification filed by Elekta Solutions Ab with the FDA for Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (new Model Variant).
| Device ID | K222047 |
| 510k Number | K222047 |
| Device Name: | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New Model Variant) |
| Classification | System, Radiation Therapy, Radionuclide |
| Applicant | Elekta Solutions AB Kungstensgatan 18 Box 7593 Stockholm, SE SE-10393 |
| Contact | Helena Skar |
| Correspondent | Helena Skar Elekta Solutions AB Kungstensgatan 18 Box 7593 Stockholm, SE 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 | 2022-07-12 |
| Decision Date | 2022-10-26 |