510(k) K211980 ยท LNH System, Nuclear Magnetic Resonance Imaging
SIGNA Prime
| Applicant | Ge Healthcare (Tianjin) Company Limited, Tianjin, CN |
| Decision | Substantially Equivalent, Jan 16, 2022 |
| Received | Jun 25, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211980
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2024 | GE Medical Systems, LLC SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Apr 21, 2022 | GE Healthcare, LLC GE Healthcare MR Systems, Magnetic Resonance imaging (MRI).
SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, 1.5T SIGNA Creator, 1.5T SIGNA Open, Classified |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.