510(k) K213668 ยท LNH System, Nuclear Magnetic Resonance Imaging
SIGNA Hero
| Applicant | Ge Healthcare (Ge Medical Systems, LLC), Waukesha WI, US |
| Decision | Substantially Equivalent, Jan 20, 2022 |
| Received | Nov 22, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213668
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2025 | GE Medical Systems, LLC GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 2, 2024 | GE Medical Systems, LLC SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; 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.