510(k) K192002 ยท LNH System, Nuclear Magnetic Resonance Imaging
Lucy Point-of-Care Magnetic Resonance Imaging Device
| Applicant | Hyperfine Research, Inc., Guildford CT, US |
| Decision | Substantially Equivalent, Feb 6, 2020 |
| Received | Jul 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192002
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.