K090972 is an FDA 510(k) clearance for the LEKSELL GAMMAPLAN. This device is classified as a System, Planning, Radiation Therapy Treatment (Class II - Special Controls, product code MUJ).
Submitted by Elekta Instrument AB (Stockholm, SE). The FDA issued a Cleared decision on July 20, 2009, 105 days after receiving the submission on April 6, 2009.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K090972 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2009 |
| Decision Date | July 20, 2009 |
| Days to Decision | 105 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MUJ - System, Planning, Radiation Therapy Treatment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |