K212456 is an FDA 510(k) clearance for the Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System. This device is classified as a System, Nuclear Magnetic Resonance Imaging (Class II - Special Controls, product code LNH).
Submitted by Hyperfine, Inc. (Guildford, US). The FDA issued a Cleared decision on November 17, 2021, 104 days after receiving the submission on August 5, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K212456 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2021 |
| Decision Date | November 17, 2021 |
| Days to Decision | 104 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 |