510(k) K253808 ยท LNH System, Nuclear Magnetic Resonance Imaging
AIR Recon DL
| Applicant | GE Medical Systems, Waukesha WI, US |
| Decision | Substantially Equivalent, Aug 13, 2026 |
| Received | Nov 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253808
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.