K051746 is an FDA 510(k) clearance for the ELEKTA ESARTE FRAME SYSTEM. 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, 2005, 26 days after receiving the submission on June 29, 2005.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 882.4560.
| 510(k) Number | K051746 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 2005 |
| Decision Date | July 25, 2005 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | HAW - Neurological Stereotaxic Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |