510(k) K121676 ยท LNH System, Nuclear Magnetic Resonance Imaging
1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Sep 20, 2012 |
| Received | Jun 7, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121676
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2024 | GE Medical Systems, LLC 3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1HD16.0_V03, HD23.0_V03; Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 2, 2024 | GE Medical Systems, LLC 1.5T SIGNA HDxt Family, 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 |
| Apr 4, 2022 | GE Healthcare, LLC 1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Dec 23, 2021 | GE Healthcare, LLC GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA HDx MR System, GE 1.5T SIGNA HDxt MR System, GE 3.0T SIGNA HDxt MR System, 1.5T SIGNA HDxt, 3.0T SIG Open, Classified |
LNH | None listed |
| Oct 16, 2021 | GE Healthcare, LLC 1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system Terminated |
LNH | None listed |
| Jul 12, 2021 | GE Healthcare, LLC 1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Jan 28, 2020 | GE Healthcare, LLC SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, hig Terminated |
LNH | None listed |
| Nov 15, 2018 | GE Healthcare, LLC Various GE Magnetic Resonance System on-site software version
Product Usage:
Magnetic resonance imaging equipment for general diagnostic use Terminated |
LNH | None listed |
| Aug 2, 2017 | GE Medical Systems, LLC 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant
Product Usage:
The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high Terminated |
LNH | None listed |
| Sep 23, 2013 | GE Healthcare, LLC GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337 Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.