510(k) K103238 ยท LNH System, Nuclear Magnetic Resonance Imaging
1.5T OPTIMA MR430S
| Applicant | Ge Medical Systems, LLC, Wilmington MA, US |
| Decision | Substantially Equivalent, Feb 11, 2011 |
| Received | Nov 2, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103238
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2021 | GE Healthcare, LLC GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR430s System, nuclear magnetic resonance imaging system. Open, Classified |
LNH | None listed |
| May 1, 2013 | GE Healthcare, LLC Optima MR430s MRI Scanner; 5000-0002
is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand. Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.