K223875 is an FDA 510(k) clearance for the MOBINEURO Alita Intraoperative MRI System. This device is classified as a System, Nuclear Magnetic Resonance Imaging (Class II - Special Controls, product code LNH).
Submitted by Sino Canada Health Engineering Research Institute (Hefei) (Hefei, CN). The FDA issued a Cleared decision on March 20, 2023, 87 days after receiving the submission on December 23, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K223875 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2022 |
| Decision Date | March 20, 2023 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | LNH - System, Nuclear Magnetic Resonance Imaging |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1000 |