K222755 is an FDA 510(k) clearance for the uMR 680. This device is classified as a System, Nuclear Magnetic Resonance Imaging (Class II - Special Controls, product code LNH).
Submitted by Shanghai United Imaging Intelligence Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on February 16, 2023, 157 days after receiving the submission on September 12, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K222755 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2022 |
| Decision Date | February 16, 2023 |
| Days to Decision | 157 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LNH - System, Nuclear Magnetic Resonance Imaging |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1000 |