510(k) K082636 ยท MOS Coil, Magnetic Resonance, Specialty
TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T
| Applicant | Quality Electrodynamics, Mayfield Village OH, US |
| Decision | Substantially Equivalent, Sep 25, 2008 |
| Received | Sep 10, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082636
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 20, 2019 | Quality Electrodynamics LLC TxRx 15Ch Knee Coil 3T
QED part number:Q7000008
Siemens Model # 10185460 Terminated |
MOS | None listed |
| Aug 20, 2019 | Quality Electrodynamics LLC TxRx 15CH Knee Coil 1.5T
QED part number:Q7000016
Siemens Model # 10185453 Terminated |
MOS | None listed |
| Aug 20, 2019 | Quality Electrodynamics LLC TxRx CP Extremity Coil 3T
QED part number: Q7000019
Siemens Model # 10185464 Terminated |
MOS | None listed |
| Aug 20, 2019 | Quality Electrodynamics LLC TxRx 15CH Knee Coil 1.5T
QED part number: Q7000050
Siemens Model # 10606524 Terminated |
MOS | None listed |
| Aug 20, 2019 | Quality Electrodynamics LLC TxRx 15CH Knee Coil 3T
QED part number: Q7000051
Siemens Model # 10606525 Terminated |
MOS | None listed |
| Aug 20, 2019 | Quality Electrodynamics LLC TxRx Knee 15 Coil 1.5T
QED part number: Q7000056
Siemens Model # 10606828 Terminated |
MOS | None listed |
| Aug 20, 2019 | Quality Electrodynamics LLC TxRx Knee 15 Coil 1.5T
QED part number: Q7000057
Siemens Model # 10606829 Terminated |
MOS | None listed |
| Sep 6, 2012 | Quality Electrodynamics LLC TxRx Knee 15 Coil 3T.
For use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee that can be interpreted by a trained physician. Terminated |
MOS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.