510(k) K213603 ยท LNH System, Nuclear Magnetic Resonance Imaging
SIGNA Artist Evo
| Applicant | Ge Healthcare (Tianjin) Company Limited, Tianjin, CN |
| Decision | Substantially Equivalent, Feb 11, 2022 |
| Received | Nov 15, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213603
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2025 | GE Medical Systems, LLC GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.