510(k) K253780 · LNH System, Nuclear Magnetic Resonance Imaging
SIGNA Bolt
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Feb 6, 2026 |
| Received | Nov 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253780
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.