K120811 is an FDA 510(k) clearance for the LEKSELL GAMMA KNIFE PERFEXION. 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 May 24, 2012, 69 days after receiving the submission on March 16, 2012.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5750.
| 510(k) Number | K120811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 2012 |
| Decision Date | May 24, 2012 |
| Days to Decision | 69 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 |