510(k) K202966 ยท LNH System, Nuclear Magnetic Resonance Imaging
SIGNA Architect
| Applicant | Ge Healthcare (Ge Medical Systems, LLC), Waukesha WI, US |
| Decision | Substantially Equivalent, Nov 13, 2020 |
| Received | Sep 30, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202966
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2025 | GE Medical Systems, LLC GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Jul 18, 2025 | GE Medical Systems, LLC SIGNA Architect Open, Classified |
LNH | None listed |
| Nov 22, 2024 | GE Medical Systems, LLC SIGNA Architect, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Nov 22, 2024 | GE Medical Systems, LLC SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 2, 2024 | GE Medical Systems, LLC SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1, DV29.2, MR30.0, MR30.1; 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 Architect system, nuclear magnetic resonance imaging system. Open, Classified |
LNH | None listed |
| Oct 16, 2021 | GE Healthcare, LLC SIGNA Architect nuclear magnetic resonance imaging system Terminated |
LNH | None listed |
| Jul 12, 2021 | GE Healthcare, LLC SIGNA Architect - 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.