K063512 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 March 5, 2007, 105 days after receiving the submission on November 20, 2006.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5750.
| 510(k) Number | K063512 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 2006 |
| Decision Date | March 05, 2007 |
| Days to Decision | 105 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 |