K031999 is an FDA 510(k) clearance for the ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT. This device is classified as a Neurological Stereotaxic Instrument (Class II - Special Controls, product code HAW).
Submitted by Elekta Instrument AB (Stockholm, SE). The FDA issued a Cleared decision on July 25, 2003, 28 days after receiving the submission on June 27, 2003.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 882.4560.
| 510(k) Number | K031999 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2003 |
| Decision Date | July 25, 2003 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | HAW - Neurological Stereotaxic Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |