Quality Electrodynamics
Mayfield Village, OH, US
QUALITY ELECTRODYNAMICS appears in FDA device records in Mayfield Village, OH. FDA records list 34 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 34 510(k) clearances for Quality Electrodynamics between 2007 and 2025. The busiest year on record is 2016, with 5. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 3 |
| 2014 | 3 |
| 2015 | 4 |
| 2016 | 5 |
| 2017 | 2 |
| 2018 | 3 |
| 2020 | 2 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K244054 | 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) | MOS | Substantially Equivalent | |
| K242006 | SureWave Elastography (Q7000225) | LNH | Substantially Equivalent | |
| K233652 | Contour Hand/Wrist (Q7000232) | MOS | Substantially Equivalent | |
| K233656 | Contour Shoulder | MOS | Substantially Equivalent | |
| K223429 | Contour Knee | MOS | Substantially Equivalent | |
| K200477 | Flex Body Speeder | MOS | Substantially Equivalent | |
| K193140 | Flex Body SPEEDER | MOS | Substantially Equivalent | |
| K183111 | Contour 24 | MOS | Substantially Equivalent | |
| K181697 | 16ch Foot/ Ankle SPEEDER | MOS | Substantially Equivalent | |
| K173469 | 16ch T/R Hand Wrist Coil | MOS | Substantially Equivalent | |
| K173446 | Contour 24 | MOS | Substantially Equivalent | |
| K162946 | 8ch Knee-Foot SPEEDER | MOS | Substantially Equivalent | |
| K162623 | 16ch T/R Hand Wrist Coil | MOS | Substantially Equivalent | |
| K162966 | TxRx Knee 15 Flare MR Coil 1.5T | MOS | Substantially Equivalent | |
| K163066 | TxRx Knee 15 Flare MR Coil 3.0T | MOS | Substantially Equivalent | |
| K162029 | 16ch T/R Knee Coil | MOS | Substantially Equivalent | |
| K161193 | 16ch Tx/Rx Knee SPEEDER | MOS | Substantially Equivalent | |
| K152695 | 8 CH Knee SPEEDER | MOS | Substantially Equivalent | |
| K151753 | 16 ch Tx/Rx Knee SPEEDER | MOS | Substantially Equivalent | |
| K151829 | Atlas SPEEDER Header/Neck | MOS | Substantially Equivalent | |
| K150331 | 18ch T/R Knee Coil | MOS | Substantially Equivalent | |
| K142802 | Atlas SPEEDER Head/Neck | MOS | Substantially Equivalent | |
| K142002 | BREAST SPEEDER CX, GRID HOLDER CX | MOS | Substantially Equivalent | |
| K140998 | PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL | MOS | Substantially Equivalent | |
| K122638 | TOSHIBA 3T 32CH HEAD SPEEDER COIL, | MOS | Substantially Equivalent | |
| K120627 | TOSHIBA 1.5T QD HEAD COIL | MOS | Substantially Equivalent | |
| K120290 | TOSHIBA 1.5T CARDIAC COIL | MOS | Substantially Equivalent | |
| K112313 | TOSHIBA 3T EXTRA LARGE KNEE COIL | MOS | Substantially Equivalent | |
| K103185 | TOSHIBA 1.5T EXTRA LARGE KNEE COIL | MOS | Substantially Equivalent | |
| K093667 | SHOULDER SPEEDER COIL | MOS | Substantially Equivalent | |
| K091114 | TXRX 1.5T CP HEAD COIL; TXRX 3T CP HEAD COIL | MOS | Substantially Equivalent | |
| K083160 | 1.5T ATLAS SPEEDER HEAD-NECK COIL | MOS | Substantially Equivalent | |
| K082636 | TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T | MOS | Substantially Equivalent | |
| K072935 | SPEEDER 1.5T WRIST ARRAY COIL | MOS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007350713 | 3007350713 | QUALITY ELECTRODYNAMICS | 6655 Beta Drive Suite 100, Mayfield Village, OH 44143 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0037-2020 | TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829 | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. | Class II | Terminated | |
| Z-0036-2020 | TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828 | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. | Class II | Terminated | |
| Z-0035-2020 | TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525 | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. | Class II | Terminated | |
| Z-0034-2020 | TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524 | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. | Class II | Terminated | |
| Z-0033-2020 | TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464 | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. | Class II | Terminated | |
| Z-0032-2020 | TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453 | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. | Class II | Terminated | |
| Z-0031-2020 | TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460 | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. | Class II | Terminated | |
| Z-2314-2012 | 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. | On July 27, 2012, it was reported to the firm that the Siemens 3T 15ch Knee Coil was not functional because the coil identification code for the device was incorrect. | Class II | Terminated | |
| Z-1938-2009 | 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 imaging. | The firm received a complaint indicating that the mirror is high risk and could drop on a patient. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain