K250597 is an FDA 510(k) clearance for the REMEX Xcam6. This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).
Submitted by Remedi, Inc. (Seoul, KR). The FDA issued a Cleared decision on July 31, 2025, 153 days after receiving the submission on February 28, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.
| 510(k) Number | K250597 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2025 |
| Decision Date | July 31, 2025 |
| Days to Decision | 153 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 |