K991571 is an FDA 510(k) clearance for the 10 CURIE IRDIUM 192, CSN00100-192. This device is classified as a Source, Brachytherapy, Radionuclide (Class II - Special Controls, product code KXK).
Submitted by Alpha-Omega Services, Inc. (Houston, US). The FDA issued a Cleared decision on February 22, 2000, 293 days after receiving the submission on May 5, 1999.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.
| 510(k) Number | K991571 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 1999 |
| Decision Date | February 22, 2000 |
| Days to Decision | 293 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KXK - Source, Brachytherapy, Radionuclide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5730 |