510(k) K083160 ยท MOS Coil, Magnetic Resonance, Specialty
1.5T ATLAS SPEEDER HEAD-NECK COIL
| Applicant | Quality Electrodynamics, Mayfield Village OH, US |
| Decision | Substantially Equivalent, Nov 7, 2008 |
| Received | Oct 27, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083160
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2009 | Quality Electrodynamics Llc Mirror assembly to magnetic resonance device (1.5T Atlas SPEEDER Head-Neck Coil) Coil Part #Q7000021, Quality Electrodynamics, Mayfield Village, OH 44143.
The indications for use are routine MR imag Terminated |
MOS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.