K042269 is an FDA 510(k) clearance for the LEKSELL GAMMAPLAN 4C WITH MULTIVIEW. 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 September 8, 2004, 16 days after receiving the submission on August 23, 2004.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K042269 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2004 |
| Decision Date | September 08, 2004 |
| Days to Decision | 16 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 |