510(k) K201722 ยท LNH System, Nuclear Magnetic Resonance Imaging
Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
| Applicant | Hyperfine Research, Inc., Guildford CT, US |
| Decision | Substantially Equivalent, Aug 11, 2020 |
| Received | Jun 23, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201722
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.