510(k) K211818 ยท LNH System, Nuclear Magnetic Resonance Imaging
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
| Applicant | Hyperfine, Inc., Guildford CT, US |
| Decision | Substantially Equivalent, Jul 7, 2021 |
| Received | Jun 11, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K211818
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.