K222987 is an FDA 510(k) clearance for the Akunah REFLECT. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Akunah Pty, Ltd. (Brisbane, AU). The FDA issued a Cleared decision on May 10, 2023, 224 days after receiving the submission on September 28, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K222987 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2022 |
| Decision Date | May 10, 2023 |
| Days to Decision | 224 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ - System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |