K241068 is an FDA 510(k) clearance for the uDR 780i. This device is classified as a System, X-ray, Stationary (Class II - Special Controls, product code KPR).
Submitted by Shanghai United Imaging Healthcare Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on November 1, 2024, 196 days after receiving the submission on April 19, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K241068 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2024 |
| Decision Date | November 01, 2024 |
| Days to Decision | 196 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPR — System, X-ray, Stationary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |