K173789 is an FDA 510(k) clearance for the Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon. This device is classified as a System, Radiation Therapy, Radionuclide (Class II - Special Controls, product code IWB).
Submitted by Elekta Instrument AB (Stockholm, SE). The FDA issued a Cleared decision on March 30, 2018, 106 days after receiving the submission on December 14, 2017.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5750.
| 510(k) Number | K173789 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 2017 |
| Decision Date | March 30, 2018 |
| 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 |