510(k) K250236 · LNH System, Nuclear Magnetic Resonance Imaging
Swoop® Portable MR Imaging® System (V2)
| Applicant | Hyperfine, Inc., Guilforf CT, US |
| Decision | Substantially Equivalent, May 30, 2025 |
| Received | Jan 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250236
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.