510(k) K110610 ยท MOS Coil, Magnetic Resonance, Specialty
1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Apr 1, 2011 |
| Received | Mar 3, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110610
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 28, 2015 | GE Medical Systems, LLC GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS.
Product Usage The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 3.0 Terminated |
MOS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.