Company ยท US
Quality Electrodynamics, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2025. Name variants (Inc, Corp, punctuation) are merged.
34510(k) clearances (0 in 12 months)
9recalls (0 in 12 months)
9recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 28, 2025 | K244054 | 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) Quality Electrodynamics | MOS |
| Feb 12, 2025 | K242006 | SureWave Elastography (Q7000225) Quality Electrodynamics, LLC | LNH |
| Feb 16, 2024 | K233652 | Contour Hand/Wrist (Q7000232) Quality Electrodynamics | MOS |
| Feb 15, 2024 | K233656 | Contour Shoulder Quality Electrodynamics | MOS |
| Jan 13, 2023 | K223429 | Contour Knee Quality Electrodynamics, LLC | MOS |
| Apr 8, 2020 | K200477 | Flex Body Speeder Quality Electrodynamics, LLC | MOS |
| Jan 3, 2020 | K193140 | Flex Body SPEEDER Quality Electrodynamics, LLC | MOS |
| Dec 7, 2018 | K183111 | Contour 24 Quality Electrodynamics, LLC | MOS |
| Jul 11, 2018 | K181697 | 16ch Foot/ Ankle SPEEDER Quality Electrodynamics, LLC | MOS |
| Jan 9, 2018 | K173469 | 16ch T/R Hand Wrist Coil Quality Electrodynamics, LLC | MOS |
| Nov 17, 2017 | K173446 | Contour 24 Quality Electrodynamics, LLC | MOS |
| Jan 6, 2017 | K162946 | 8ch Knee-Foot SPEEDER Quality Electrodynamics, LLC | MOS |
| Dec 9, 2016 | K162623 | 16ch T/R Hand Wrist Coil Quality Electrodynamics, LLC | MOS |
| Nov 30, 2016 | K162966 | TxRx Knee 15 Flare MR Coil 1.5T Quality Electrodynamics, LLC | MOS |
| Nov 29, 2016 | K163066 | TxRx Knee 15 Flare MR Coil 3.0T Quality Electrodynamics, LLC | MOS |
| Oct 18, 2016 | K162029 | 16ch T/R Knee Coil Quality Electrodynamics, LLC | MOS |
| Jun 2, 2016 | K161193 | 16ch Tx/Rx Knee SPEEDER Quality Electrodynamics, LLC | MOS |
| Nov 18, 2015 | K152695 | 8 CH Knee SPEEDER Quality Electrodynamics, LLC | MOS |
| Aug 27, 2015 | K151753 | 16 ch Tx/Rx Knee SPEEDER Quality Electrodynamics, LLC | MOS |
| Jul 29, 2015 | K151829 | Atlas SPEEDER Header/Neck Quality Electrodynamics, LLC | MOS |
| Apr 9, 2015 | K150331 | 18ch T/R Knee Coil Quality Electrodynamics, LLC | MOS |
| Nov 24, 2014 | K142802 | Atlas SPEEDER Head/Neck Quality Electrodynamics, LLC | MOS |
| Aug 22, 2014 | K142002 | BREAST SPEEDER CX, GRID HOLDER CX Quality Electrodynamics, LLC | MOS |
| Jul 11, 2014 | K140998 | PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL Quality Electrodynamics, LLC | MOS |
| Sep 25, 2012 | K122638 | TOSHIBA 3T 32CH HEAD SPEEDER COIL, Quality Electrodynamics | MOS |
| Mar 29, 2012 | K120627 | TOSHIBA 1.5T QD HEAD COIL Quality Electrodynamics | MOS |
| Feb 28, 2012 | K120290 | TOSHIBA 1.5T CARDIAC COIL Quality Electrodynamics | MOS |
| Sep 9, 2011 | K112313 | TOSHIBA 3T EXTRA LARGE KNEE COIL Quality Electrodynamics | MOS |
| Feb 25, 2011 | K103185 | TOSHIBA 1.5T EXTRA LARGE KNEE COIL Quality Electrodynamics | MOS |
| Jan 28, 2010 | K093667 | SHOULDER SPEEDER COIL Quality Electrodynamics | MOS |
| May 1, 2009 | K091114 | TXRX 1.5T CP HEAD COIL; TXRX 3T CP HEAD COIL Quality Electrodynamics | MOS |
| Nov 7, 2008 | K083160 | 1.5T ATLAS SPEEDER HEAD-NECK COIL Quality Electrodynamics | MOS |
| Sep 25, 2008 | K082636 | TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T Quality Electrodynamics | MOS |
| Oct 31, 2007 | K072935 | SPEEDER 1.5T WRIST ARRAY COIL Quality Electrodynamics | MOS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 20, 2019 | Quality Electrodynamics LLC TxRx Knee 15 Coil 1.5T
QED part number: Q7000057
Siemens Model # 10606829 Terminated |
MOS | K082636 |
| Aug 20, 2019 | Quality Electrodynamics LLC TxRx Knee 15 Coil 1.5T
QED part number: Q7000056
Siemens Model # 10606828 Terminated |
MOS | K082636 |
| Aug 20, 2019 | Quality Electrodynamics LLC TxRx 15CH Knee Coil 3T
QED part number: Q7000051
Siemens Model # 10606525 Terminated |
MOS | K082636 |
| Aug 20, 2019 | Quality Electrodynamics LLC TxRx 15CH Knee Coil 1.5T
QED part number: Q7000050
Siemens Model # 10606524 Terminated |
MOS | K082636 |
| Aug 20, 2019 | Quality Electrodynamics LLC TxRx CP Extremity Coil 3T
QED part number: Q7000019
Siemens Model # 10185464 Terminated |
MOS | K082636 |
| Aug 20, 2019 | Quality Electrodynamics LLC TxRx 15CH Knee Coil 1.5T
QED part number:Q7000016
Siemens Model # 10185453 Terminated |
MOS | K082636 |
| Aug 20, 2019 | Quality Electrodynamics LLC TxRx 15Ch Knee Coil 3T
QED part number:Q7000008
Siemens Model # 10185460 Terminated |
MOS | K082636 |
| 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 | K082636 |
| 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 | K083160 |