K232158 is an FDA 510(k) clearance for the GenX-CR. This device is classified as a System, X-ray, Extraoral Source, Digital (Class II - Special Controls, product code MUH).
Submitted by Genoray Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on September 13, 2023, 55 days after receiving the submission on July 20, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.
| 510(k) Number | K232158 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 2023 |
| Decision Date | September 13, 2023 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MUH — System, X-ray, Extraoral Source, Digital |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1800 |