510(k) K253489 · LNH System, Nuclear Magnetic Resonance Imaging
Swoop® Portable MR Imaging® System
| Applicant | Hyperfine, Inc., Guilforf CT, US |
| Decision | Substantially Equivalent, Dec 12, 2025 |
| Received | Oct 24, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253489
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.