510(k) K192426 ยท LNH System, Nuclear Magnetic Resonance Imaging
Signa Voyager, Signa Voyager Quantum
| Applicant | Ge Healthcare (Tianjin) Company Limited, Tianjin, CN |
| Decision | Substantially Equivalent, Oct 1, 2019 |
| Received | Sep 5, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192426
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2025 | GE Medical Systems, LLC GE Signa Voyager, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Dec 23, 2021 | GE Healthcare, LLC GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voyager and SIGNA Voyager Premier Edition system, nuclear magnetic resonance imaging system. Open, Classified |
LNH | None listed |
| Oct 16, 2021 | GE Healthcare, LLC SIGNA Voyager nuclear magnetic resonance imaging system Terminated |
LNH | None listed |
| Jul 12, 2021 | GE Healthcare, LLC SIGNA Voyager, 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.