510(k) K201615 ยท LNH System, Nuclear Magnetic Resonance Imaging
SIGNA 7.0T
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Oct 15, 2020 |
| Received | Jun 15, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201615
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2024 | GE Medical Systems, LLC SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.