510(k) K193282 ยท LNH System, Nuclear Magnetic Resonance Imaging
SIGNA Premier
| Applicant | Ge Healthcare (Ge Medical Systems, LLC), Waukesha WI, US |
| Decision | Substantially Equivalent, Apr 10, 2020 |
| Received | Nov 27, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193282
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2026 | GE Healthcare LLC SIGNA Premier systems Open, Classified |
LNH | None listed |
| Aug 13, 2025 | GE Medical Systems, LLC GE SIGNA Premier, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 2, 2024 | GE Medical Systems, LLC SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Jun 24, 2022 | GE Healthcare, LLC SIGNA Premier magnetic resonance scanner, model 5748519. Open, Classified |
LNH | None listed |
| Dec 23, 2021 | GE Healthcare, LLC GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance imaging system. Open, Classified |
LNH | None listed |
| Oct 16, 2021 | GE Healthcare, LLC SIGNA Premier nuclear magnetic resonance imaging system Terminated |
LNH | None listed |
| Jul 12, 2021 | GE Healthcare, LLC SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. Open, Classified |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.