K223465 is an FDA 510(k) clearance for the RadianceTx Radionuclide Brachytherapy Source. This device is classified as a Source, Brachytherapy, Radionuclide (Class II - Special Controls, product code KXK).
Submitted by Radiance Therapeutics, Inc. (Tucson, US). The FDA issued a Cleared decision on January 11, 2023, 55 days after receiving the submission on November 17, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.
| 510(k) Number | K223465 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2022 |
| Decision Date | January 11, 2023 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | KXK - Source, Brachytherapy, Radionuclide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5730 |