Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007350713

FEI Number

3007350713

Entity Name

QUALITY ELECTRODYNAMICS

City/State/Country

Mayfield Village, OH, US

Establishment Address

6655 Beta Drive Suite 100, Mayfield Village, OH 44143, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Quality Electrodynamics (Owner Number: 10023379)

Owner / Operator Contact Address

6655 Beta Drive, Suite 100, Mayfield Village, OH 44143, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K142002

PMA Number

N/A

All Registered Proprietary Names

Contour Shoulder 16ch T/R Hand Wrist Coil TxRx CP Head Coil 1Tx28x Knee Coil 7T Clinic Flex Body SPEEDER TxRx Knee 15 Coil TxRx 15ch Knee Coil TxRx CP Extremity Coil 16ch Foot/Ankle SPEEDER Contour 24 2Tx-28Rx Knee Coil Phantoms 8ch Knee SPEEDER 16ch Flex SPEEDER 1.5T 16ch T/R Knee Coil TxRx Knee 15 Flare MR Coil 3T Contour 24 32ch Head SPEEDER Coil Atlas SPEEDER Head/Neck SureWave Elastography 32ch Cardiac SPEEDER Coil Flex Body SPEEDER 18ch T/R Knee Coil 16ch T/R Hand Wrist Coil Extra Large Knee SPEEDER Coil (Tx/Rx) Head-Neck Coil Medium Torso Coil 8ch Knee-Foot SPEEDER Contour Knee Atlas SPEEDER Head/Neck 16ch TxRx Knee SPEEDER Breast SPEEDER CX Grid Holder CX Breast Riser CX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2025-03-04
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2016-12-09
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2012-07-18
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2017-11-13
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2021-07-06
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2012-07-18
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2018-09-04
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2019-01-18
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2020-10-26
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2020-10-26
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2020-10-26
LHO	Instrument, Quality-Assurance, Radiologic	Radiology	Class 1	892.1940	2020-02-04
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2015-12-07
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2025-03-04
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2016-11-23
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2016-12-01
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2018-05-30
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2012-11-28
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2015-01-19
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2025-02-13
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2012-07-18
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2020-07-30
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2015-04-15
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2018-01-25
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2012-07-18
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2014-03-27
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2017-01-10
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2023-01-17
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2015-09-04
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2015-09-04
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2014-11-11

Official Correspondent

Kathleen Aras

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Quality Electrodynamics

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K121249	Paramed S.R.L.	MULTIARRAY KIT	2012-06-12
K000935	Mri Devices Corp.	KFA-63 KNEE AND FOOT ARRAY	2000-04-07
K102889	Hitachi Medical Systems America, Inc.	HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON	2010-12-20
K110373	Esaote, S.p.A.	TEMPOROMANIBULAR COIL 15	2011-04-06
K030317	Midwest Rf, LLC	MODEL 1300GE-64: PEDIATRIC POSITIONER	2003-03-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2020	Quality Electrodynamics LLC	2	TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460
Z-0032-2020	Quality Electrodynamics LLC	2	TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453
Z-0033-2020	Quality Electrodynamics LLC	2	TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464
Z-0034-2020	Quality Electrodynamics LLC	2	TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524
Z-0035-2020	Quality Electrodynamics LLC	2	TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525
Z-0036-2020	Quality Electrodynamics LLC	2	TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828
Z-0037-2020	Quality Electrodynamics LLC	2	TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007350713. Last updated year: 2026. Please use registration number 3007350713 when referencing this establishment in official correspondence.