K231273 is an FDA 510(k) clearance for the ArcherQA (V1.0). This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).
Submitted by Wisdom Technologies., Inc. (Hefei, CN). The FDA issued a Cleared decision on January 5, 2024, 248 days after receiving the submission on May 2, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K231273 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2023 |
| Decision Date | January 05, 2024 |
| Days to Decision | 248 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYE - Accelerator, Linear, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |