K102811 is an FDA 510(k) clearance for the AOS ORION IR-192 SOURCE CABLE. This device is classified as a Source, Brachytherapy, Radionuclide (Class II - Special Controls, product code KXK).
Submitted by Alpha-Omega Services, Inc. (Bellflower, US). The FDA issued a Cleared decision on June 2, 2011, 247 days after receiving the submission on September 28, 2010.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.
| 510(k) Number | K102811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2010 |
| Decision Date | June 02, 2011 |
| Days to Decision | 247 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 |