510(k) K103335 ยท MOS Coil, Magnetic Resonance, Specialty
GEM OPTION FOR 1.5 MRI SYSTEMS
| Applicant | GE Healthcare, Aurora OH, US |
| Decision | Substantially Equivalent, Mar 7, 2011 |
| Received | Nov 15, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103335
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2014 | GE Healthcare, LLC GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery MR750w equipped with the GEM option products.
Affected devic Terminated |
LNH | None listed |
| Apr 21, 2014 | GE Healthcare, LLC GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products. Magnetic Resonance Diagnostic Device. Terminated |
LNH | None listed |
| May 4, 2012 | GE Healthcare, LLC GE Healthcare, Optima MR450W with GEM.
Product Usage - The GEM Option for 1 .5T MRI systems is a set of receive-only RF surface coils designed for use with 1 .5T MRI systems manufactured by GE Health Terminated |
MOS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.