K160440 is an FDA 510(k) clearance for the 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 April 20, 2016, 63 days after receiving the submission on February 17, 2016.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5750.
| 510(k) Number | K160440 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 2016 |
| Decision Date | April 20, 2016 |
| Days to Decision | 63 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 |