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Sign in to claim this brandQUALITY ELECTRODYNAMICS LLC
United States·US-MF-000001417
Last updated May 25, 2026
Information
- Country
- United States
- Address
- 6655, Beta Drive , Mayfield Village, United States
- Website
- www.qualityelectrodynamics.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Craig Woodworth
- EUDAMED SRN
- US-MF-000001417
- FDA FEI Number
- —
- DUNS Number
- 614760119
Catalogue (92)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 32ch Head SPEEDER Coil | Q7000032 | FDA UDI | Class II | Active |
| Head Neck Simulator | 2001000 | FDA UDI | Class II | Active |
| Atlas SPEEDER Head-Neck Coil | Q7000021 | FDA UDI | Class II | Active |
| Medium Torso Simulator | 2001001 | FDA UDI | Class II | Active |
| Shape Coil | Q7000198 | FDA UDI | Class II | Active |
| 16ch Tx/Rx Knee SPEEDER Coil | Q7000160 | FDA UDI | Class II | Active |
| Wrist SPEEDER Coil | Q7000005 | FDA UDI | Class II | Active |
| Shape Coil | Q7000199 | FDA UDI | Class II | Active |
| 8ch Knee SPEEDER Coil | Q7000166 | FDA UDI | Class II | Active |
| 16ch Tx/Rx Knee SPEEDER Coil | Q7000147 | FDA UDI | Class II | Active |
| Head Neck Coil | Q7000076 | FDA UDI | Class II | Active |
| Breast Riser CX | MAC000109 | FDA UDI | Class I | Active |
| 32ch Cardiac SPEEDER Coil | Q7000020 | FDA UDI | Class II | Active |
| Atlas SPEEDER Head-Neck Coil | Q7000049 | FDA UDI | Class II | Active |
| Tx/Rx Extra Large Knee Coil | Q7000006 | FDA UDI | Class II | Active |
| Shoulder SPEEDER Coil | Q7000018 | FDA UDI | Class II | Active |
| Atlas SPEEDER Spine Coil | Q7000035 | FDA UDI | Class II | Active |
| 16ch Flex SPEEDER Large 1.5T | Q7000247 | FDA UDI | Class II | Active |
| Atlas SPEEDER Head/Neck Coil | Q7000126 | FDA UDI | Class II | Active |
| 16ch Foot/Ankle SPEEDER | Q7000073 | FDA UDI | Class II | Active |
| Breast SPEEDER CX Coil | Q7000125 | FDA UDI | Class II | Active |
| Wrist SPEEDER Coil | Q7000081 | FDA UDI | Class II | Active |
| Extra Large Knee SPEEDER Coil (Tx/Rx) | Q7000037 | FDA UDI | Class II | Active |
| 16ch Flex SPEEDER Medium 1.5T | Q7000246 | FDA UDI | Class II | Active |
| Grid Holder CX | MAC000110 | FDA UDI | Class II | Active |
| 8ch Knee-Foot SPEEDER Coil | Q7000172 | FDA UDI | Class II | Active |
| Atlas SPEEDER Head/Neck Coil | Q7000146 | FDA UDI | Class II | Active |
| SureWave Elastography | Q7000225 | FDA UDI | Class II | Active |
| Medium Torso Coil | Q7000066 | FDA UDI | Class II | Active |
| T/R QD Head Coil | Q7000092 | FDA UDI | Class II | Active |
| 1H/31P TxRx CP Head | Q7000108 | EUDAMED | Class IIa | Active |
| 16ch T/R Hand Wrist Coil | Q7000180 | EUDAMEDFDA UDI | Class IIa | Active |
| 1H/31P TxRx Loop | Q7000104 | EUDAMED | Class IIa | Active |
| Shoulder Speeder Coil | K093667 | FDA 510(k) | Class II | Active |
| Flex Body SPEEDER | K193140 | FDA 510(k) | Class II | Active |
| SureWave Elastography (Q7000225) | K242006 | FDA 510(k) | Class II | Active |
| 8ch Knee-Foot SPEEDER | K162946 | FDA 510(k) | Class II | Active |
| Toshiba 1.5t Extra Large Knee Coil | K103185 | FDA 510(k) | Class II | Active |
| 1.5t Atlas Speeder Head-Neck Coil | K083160 | FDA 510(k) | Class II | Active |
| 8 CH Knee SPEEDER | K152695 | FDA 510(k) | Class II | Active |
| Toshiba 1.5t Qd Head Coil | K120627 | FDA 510(k) | Class II | Active |
| TxRx Knee 15 Flare MR Coil 3.0T | K163066 | FDA 510(k) | Class II | Active |
| Speeder 1.5t Wrist Array Coil | K072935 | FDA 510(k) | Class II | Active |
| Atlas SPEEDER Head/Neck | K142802 | FDA 510(k) | Class II | Active |
| Toshiba 1.5t Cardiac Coil | K120290 | FDA 510(k) | Class II | Active |
| TxRx Knee 15 Flare MR Coil 1.5T | K162966 | FDA 510(k) | Class II | Active |
| Flex Body Speeder | K200477 | FDA 510(k) | Class II | Active |
| Pediatric 16, A1.5t Tim Coil/Pediatric 16, A3t Tim Coil | K140998 | FDA 510(k) | Class II | Active |
| Toshiba 3t 32ch Head Speeder Coil, | K122638 | FDA 510(k) | Class II | Active |
| 16 ch Tx/Rx Knee SPEEDER | K151753 | FDA 510(k) | Class II | Active |
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FDA Recalls (9)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Aug 20, 2019 | Z-0031-2020 | — | terminated | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. |
| Aug 20, 2019 | Z-0037-2020 | — | terminated | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. |
| Aug 20, 2019 | Z-0036-2020 | — | terminated | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. |
| Aug 20, 2019 | Z-0035-2020 | — | terminated | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. |
| Aug 20, 2019 | Z-0034-2020 | — | terminated | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. |
| Aug 20, 2019 | Z-0032-2020 | — | terminated | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. |
| Aug 20, 2019 | Z-0033-2020 | — | terminated | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. |
| Jul 27, 2012 | Z-2314-2012 | — | terminated | 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. |
| Dec 29, 2008 | Z-1938-2009 | — | terminated | The firm received a complaint indicating that the mirror is high risk and could drop on a patient. |