K192650 is an FDA 510(k) clearance for the i_Space 1.5T Superconducting Magnetic Resonance Imaging System. This device is classified as a System, Nuclear Magnetic Resonance Imaging (Class II - Special Controls, product code LNH).
Submitted by Mri Division,Beijing Wandong Medical Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on January 29, 2021, 493 days after receiving the submission on September 24, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K192650 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2019 |
| Decision Date | January 29, 2021 |
| Days to Decision | 493 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 |