K234108 is an FDA 510(k) clearance for the ERI Portable X-ray System (CVX-air). This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).
Submitted by Energy Resources International Co., Ltd. (Hsinchu County, TW). The FDA issued a Cleared decision on September 20, 2024, 268 days after receiving the submission on December 27, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.
| 510(k) Number | K234108 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2023 |
| Decision Date | September 20, 2024 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZL - System, X-ray, Mobile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1720 |