K242515 is an FDA 510(k) clearance for the uDR 380i Pro. This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).
Submitted by Shanghai United Imaging Healthcare Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on October 10, 2024, 48 days after receiving the submission on August 23, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.
| 510(k) Number | K242515 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2024 |
| Decision Date | October 10, 2024 |
| Days to Decision | 48 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 |