K222047 is an FDA 510(k) clearance for the Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant). This device is classified as a System, Radiation Therapy, Radionuclide (Class II - Special Controls, product code IWB).
Submitted by Elekta Solutions AB (Stockholm, SE). The FDA issued a Cleared decision on October 26, 2022, 106 days after receiving the submission on July 12, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5750.
| 510(k) Number | K222047 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2022 |
| Decision Date | October 26, 2022 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IWB — System, Radiation Therapy, Radionuclide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5750 |