510(k) K143251 ยท LNH System, Nuclear Magnetic Resonance Imaging
SIGNA Creator, SIGNA Explorer
| Applicant | Ge Healthcare (Ge Medical Systems, LLC), Waukesha WI, US |
| Decision | Substantially Equivalent, Feb 4, 2015 |
| Received | Nov 12, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143251
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 28, 2025 | GE Healthcare (China) Co., Ltd. SIGNA Creator, SIGNA Explorer, NMRI systems Open, Classified |
LNH | None listed |
| Feb 28, 2025 | GE Healthcare (China) Co., Ltd. SIGNA MR355, SIGNA MR360, NMRI system Open, Classified |
LNH | None listed |
| Aug 2, 2024 | GE Medical Systems, LLC SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 2, 2024 | GE Medical Systems, LLC SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 2, 2024 | GE Medical Systems, LLC SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 2, 2024 | GE Medical Systems, LLC SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 2, 2024 | GE Medical Systems, LLC SIGNA MR360, with affected software versions: SV25.5, SV25.6; 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 Creator and SIGNA Explorer System, 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 MR355 and SIGNA MR360 System, nuclear magnetic resonance imaging system. Open, Classified |
LNH | None listed |
| Oct 16, 2021 | GE Healthcare, LLC SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system Terminated |
LNH | None listed |
| Jul 12, 2021 | GE Healthcare, LLC SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Jul 12, 2021 | GE Healthcare, LLC SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 2, 2017 | GE Medical Systems, LLC SIGNA Creator, SIGNA ExplorerProduct Usage:
1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and Terminated |
LNH | None listed |
| Aug 31, 2016 | GE Healthcare, LLC GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device. Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.