K211406 is an FDA 510(k) clearance for the OASIS MRI System. This device is classified as a System, Nuclear Magnetic Resonance Imaging (Class II - Special Controls, product code LNH).
Submitted by Hitachi Healthcare Americas (Twinsburg, US). The FDA issued a Cleared decision on October 7, 2021, 154 days after receiving the submission on May 6, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K211406 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2021 |
| Decision Date | October 07, 2021 |
| Days to Decision | 154 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 |