K180515 is an FDA 510(k) clearance for the GammaTile. This device is classified as a Source, Brachytherapy, Radionuclide (Class II - Special Controls, product code KXK).
Submitted by Isoray Medical, Inc. (Richland, US). The FDA issued a Cleared decision on July 6, 2018, 129 days after receiving the submission on February 27, 2018.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.
| 510(k) Number | K180515 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 2018 |
| Decision Date | July 06, 2018 |
| Days to Decision | 129 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 |