K230611 is an FDA 510(k) clearance for the X80 / RADiant / PhotoElectric Therapy System (RADiant Aura). This device is classified as a System, Therapeutic, X-ray (Class II - Special Controls, product code JAD).
Submitted by Xstrahl, Ltd. (Brownhills, GB). The FDA issued a Cleared decision on July 13, 2023, 129 days after receiving the submission on March 6, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5900.
| 510(k) Number | K230611 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2023 |
| Decision Date | July 13, 2023 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAD - System, Therapeutic, X-ray |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5900 |