510(k) K030371 ยท MOS Coil, Magnetic Resonance, Specialty
PRIMA III TOTALSENSE TORSO COIL
| Applicant | Usa Instruments, Inc., Aurora OH, US |
| Decision | Substantially Equivalent, May 5, 2003 |
| Received | Feb 4, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030371
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | USA Instruments Inc. Prima III TotalSENSE Torso Coil (Body Array Coil), labeled as Manufactured by: USA Instruments, Inc. This device is a component of the Magnetom TRIO 3.0T MRI Systems, manufactured by Siemens AG Medic Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.