K193324 is an FDA 510(k) clearance for the Motion Correction System. This device is classified as a System, Nuclear Magnetic Resonance Imaging (Class II - Special Controls, product code LNH).
Submitted by Kineticor, Inc. (Honolulu, US). The FDA issued a Cleared decision on February 4, 2020, 64 days after receiving the submission on December 2, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K193324 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2019 |
| Decision Date | February 04, 2020 |
| Days to Decision | 64 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 |