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QUALITY 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
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Craig Woodworth
EUDAMED SRN: US-MF-000001417
FDA FEI Number: —
DUNS Number: 614760119

Catalogue (92)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
Txrx 1.5t Cp Head Coil; Txrx 3t Cp Head Coil	K091114	FDA 510(k)	Class II	Active
Txrx 15ch Knee Coil (1.5t And 3t), Txrx Cp Extremity Coil 3t	K082636	FDA 510(k)	Class II	Active
16ch Tx/Rx Knee SPEEDER	K161193	FDA 510(k)	Class II	Active
Toshiba 3t Extra Large Knee Coil	K112313	FDA 510(k)	Class II	Active
16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)	K244054	FDA 510(k)	Class II	Active
16ch Foot/ Ankle SPEEDER	K181697	FDA 510(k)	Class II	Active
Atlas SPEEDER Header/Neck	K151829	FDA 510(k)	Class II	Active
Breast Speeder Cx, Grid Holder Cx	K142002	FDA 510(k)	Class II	Active
16ch T/R Knee Coil	Q7000075	EUDAMEDFDA UDI	Class IIa	Active
1H/19F TxRx Loop	Q7000105	EUDAMED	Class IIa	Active
1H/23Na TxRx CP Head	Q7000106	EUDAMED	Class IIa	Active
TxRx CP Head Coil	Q7000059	EUDAMEDFDA UDI	Class IIa	Active
16ch T/R Hand Wrist Coil	Q7000152	EUDAMEDFDA UDI	Class IIa	Active
Contour Shoulder	Q7000222	EUDAMEDFDA UDI	Class IIa	Active
TxRx 15CH Knee Coil	Q7000051	EUDAMEDFDA UDI	Class IIa	Active
TxRx Knee Flare MR Coil 3.0T	Q7000168	EUDAMEDFDA UDI	Class IIa	Active
Contour 24	Q7000184	EUDAMEDFDA UDI	Class IIa	Active
1H/19F TxRx CP Head	Q7000109	EUDAMED	Class IIa	Active
TxRx Knee Flare MR Coil	Q7000167	EUDAMEDFDA UDI	Class IIa	Active
TxRx CP Extremity Coil	Q7000019	EUDAMEDFDA UDI	Class IIa	Active
16ch T/R Hand Wrist Coil	Q7000238	EUDAMEDFDA UDI	Class IIa	Active
TxRx 15ch Knee Coil	Q7000008	EUDAMEDFDA UDI	Class IIa	Active
Contour Hand Wrist	Q7000232	EUDAMED	Class IIa	Active
2Tx 28Rx Knee Coil	Q7000188	EUDAMEDFDA UDI	Class IIa	Active
Contour Knee	Q7000187	EUDAMEDFDA UDI	Class IIa	Active
1H/13C TxRx CP Head	Q7000107	EUDAMED	Class IIa	Active
TxRx 15CH Knee Coil	Q7000050	EUDAMEDFDA UDI	Class IIa	Active
8Tx30Rx Knee 7T	Q7000204	EUDAMED	Class IIa	Active
1H/13C TxRx Loop	Q7000103	EUDAMED	Class IIa	Active
TxRx CP Extremity	Q7000052	EUDAMEDFDA UDI	Class IIa	Active
TxRx 15CH Knee Coil	Q7000056	EUDAMEDFDA UDI	Class IIa	Active
TxRx CP Head Coil	Q7000026	EUDAMEDFDA UDI	Class IIa	Active
18ch T/R Knee Coil	Q7000074	EUDAMEDFDA UDI	Class IIa	Active
TxRx 15CH Knee Coil	Q7000057	EUDAMEDFDA UDI	Class IIa	Active
Contour 24	Q7000183	EUDAMEDFDA UDI	Class IIa	Active
TxRx CP Head Coil	Q7000027	EUDAMEDFDA UDI	Class IIa	Active
8Tx24Rx Hand Wrist 7T	Q7000205	EUDAMED	Class IIa	Active
1H/23Na TxRx Loop	Q7000102	EUDAMED	Class IIa	Active
Pediatric 16	Q7000137	EUDAMEDFDA UDI	Class IIa	Active
1Tx28Rx Knee Coil 7T Clinic	Q7000174	EUDAMEDFDA UDI	Class IIa	Active
TxRx CP Head Coil	Q7000060	EUDAMEDFDA UDI	Class IIa	Active
Pediatric 16	Q7000061	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.