K233628 is an FDA 510(k) clearance for the AOS Interstitial Templates, Needles, and Accessories. This device is classified as a System, Applicator, Radionuclide, Remote-controlled (Class II - Special Controls, product code JAQ).
Submitted by Alpha-Omega Services, Inc. (Bellflower, US). The FDA issued a Cleared decision on July 10, 2024, 240 days after receiving the submission on November 13, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5700.
| 510(k) Number | K233628 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2023 |
| Decision Date | July 10, 2024 |
| Days to Decision | 240 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAQ - System, Applicator, Radionuclide, Remote-controlled |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5700 |