510(k) K103342 ยท MOS Coil, Magnetic Resonance, Specialty
3.0T METAFLEXCOIL
| Applicant | Neocoil, LLC, Pewaukee WI, US |
| Decision | Substantially Equivalent, Dec 23, 2010 |
| Received | Nov 15, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103342
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2015 | NeoCoil, LLC NeoCoil 3.0T GEM Flex Coil.
The 3.0T GEM Flex coil system includes three sizes of coil arrays and one interface box.
3.0T GEM Flex, Interface 16ch Fixed, P -Connector, NC032204, GEHC part number 543 Terminated |
MOS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.