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Data / Medical devices / United States / Quality Electrodynamics

Quality Electrodynamics: FDA-registered device maker in Mayfield Village, OH, United States, 37 510(k) clearances

Quality Electrodynamics is registered with the FDA (registration 3007350713) in Mayfield Village, OH, United States. It lists 5 device types. The FDA files 37 510(k) clearances under its listings, the newest dated February 28, 2025. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Quality Electrodynamics
FDA registration number
3007350713
Address
6655 Beta Drive Suite 100, Mayfield Village, OH, United States, 44143
Owner or operator
Quality Electrodynamics (10023379)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer
First device listed
November 21, 2007
Registered through
2026
Brand names listed
16 ch TxRx Knee SPEEDER, 16ch Flex SPEEDER 1.5T, 16ch Foot/Ankle SPEEDER, 16ch T/R Hand Wrist Coil, 16ch T/R Knee Coil, 16ch TxRx Knee SPEEDER, 18ch T/R Knee Coil, 1Tx28x Knee Coil 7T Clinic and more

Devices it lists

DeviceProduct codeClassRoleSource
Accelerator, Linear, MedicalIYE2Contract manufactureraccessdata.fda.gov
Coil, Magnetic Resonance, SpecialtyMOS2Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Specification developeraccessdata.fda.gov
Instrument, Quality-Assurance, RadiologicLHO1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
System, Nuclear Magnetic Resonance ImagingLNH2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
System, Nuclear Magnetic Resonance SpectroscopicLNI2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 28, 2025K24405416ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)MOSSubstantially EquivalentQuality Electrodynamicsaccessdata.fda.gov
February 12, 2025K242006SureWave Elastography (Q7000225)LNHSubstantially EquivalentQuality Electrodynamics, LLCaccessdata.fda.gov
February 16, 2024K233652Contour Hand/Wrist (Q7000232)MOSSubstantially EquivalentQuality Electrodynamicsaccessdata.fda.gov
February 15, 2024K233656Contour ShoulderMOSSubstantially EquivalentQuality Electrodynamicsaccessdata.fda.gov
January 13, 2023K223429Contour KneeMOSSubstantially EquivalentQuality Electrodynamics, LLCaccessdata.fda.gov
October 15, 2020K201615SIGNA 7.0TLNHSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
April 8, 2020K200477Flex Body SpeederMOSSubstantially EquivalentQuality Electrodynamics, LLCaccessdata.fda.gov
January 3, 2020K193140Flex Body SPEEDERMOSSubstantially EquivalentQuality Electrodynamics, LLCaccessdata.fda.gov
December 7, 2018K183111Contour 24MOSSubstantially EquivalentQuality Electrodynamics, LLCaccessdata.fda.gov
July 11, 2018K18169716ch Foot/ Ankle SPEEDERMOSSubstantially EquivalentQuality Electrodynamics, LLCaccessdata.fda.gov
January 9, 2018K17346916ch T/R Hand Wrist CoilMOSSubstantially EquivalentQuality Electrodynamics, LLCaccessdata.fda.gov
November 17, 2017K173446Contour 24MOSSubstantially EquivalentQuality Electrodynamics, LLCaccessdata.fda.gov
October 12, 2017K170840MAGNETOM TerraLNHSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
January 6, 2017K1629468ch Knee-Foot SPEEDERMOSSubstantially EquivalentQuality Electrodynamics, LLCaccessdata.fda.gov
December 9, 2016K16262316ch T/R Hand Wrist CoilMOSSubstantially EquivalentQuality Electrodynamics, LLCaccessdata.fda.gov
November 30, 2016K162966TxRx Knee 15 Flare MR Coil 1.5TMOSSubstantially EquivalentQuality Electrodynamics, LLCaccessdata.fda.gov
November 29, 2016K163066TxRx Knee 15 Flare MR Coil 3.0TMOSSubstantially EquivalentQuality Electrodynamics, LLCaccessdata.fda.gov
October 18, 2016K16202916ch T/R Knee CoilMOSSubstantially EquivalentQuality Electrodynamics, LLCaccessdata.fda.gov
June 2, 2016K16119316ch Tx/Rx Knee SPEEDERMOSSubstantially EquivalentQuality Electrodynamics, LLCaccessdata.fda.gov
November 18, 2015K1526958 CH Knee SPEEDERMOSSubstantially EquivalentQuality Electrodynamics, LLCaccessdata.fda.gov
August 27, 2015K15175316 ch Tx/Rx Knee SPEEDERMOSSubstantially EquivalentQuality Electrodynamics, LLCaccessdata.fda.gov
July 29, 2015K151829Atlas SPEEDER Header/NeckMOSSubstantially EquivalentQuality Electrodynamics, LLCaccessdata.fda.gov
April 9, 2015K15033118ch T/R Knee CoilMOSSubstantially EquivalentQuality Electrodynamics, LLCaccessdata.fda.gov
November 24, 2014K142802Atlas SPEEDER Head/NeckMOSSubstantially EquivalentQuality Electrodynamics, LLCaccessdata.fda.gov
August 22, 2014K142002BREAST SPEEDER CX, GRID HOLDER CXMOSSubstantially EquivalentQuality Electrodynamics, LLCaccessdata.fda.gov
July 11, 2014K140998PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COILMOSSubstantially EquivalentQuality Electrodynamics, LLCaccessdata.fda.gov
September 25, 2012K122638TOSHIBA 3T 32CH HEAD SPEEDER COIL,MOSSubstantially EquivalentQuality Electrodynamicsaccessdata.fda.gov
March 29, 2012K120627TOSHIBA 1.5T QD HEAD COILMOSSubstantially EquivalentQuality Electrodynamicsaccessdata.fda.gov
February 28, 2012K120290TOSHIBA 1.5T CARDIAC COILMOSSubstantially EquivalentQuality Electrodynamicsaccessdata.fda.gov
September 9, 2011K112313TOSHIBA 3T EXTRA LARGE KNEE COILMOSSubstantially EquivalentQuality Electrodynamicsaccessdata.fda.gov
August 2, 2011K102489VANTAGE TITAN 3TLNHSubstantially EquivalentToshiba Medical Systems Corporation, Japanaccessdata.fda.gov
February 25, 2011K103185TOSHIBA 1.5T EXTRA LARGE KNEE COILMOSSubstantially EquivalentQuality Electrodynamicsaccessdata.fda.gov
January 28, 2010K093667SHOULDER SPEEDER COILMOSSubstantially EquivalentQuality Electrodynamicsaccessdata.fda.gov
May 1, 2009K091114TXRX 1.5T CP HEAD COIL; TXRX 3T CP HEAD COILMOSSubstantially EquivalentQuality Electrodynamicsaccessdata.fda.gov
November 7, 2008K0831601.5T ATLAS SPEEDER HEAD-NECK COILMOSSubstantially EquivalentQuality Electrodynamicsaccessdata.fda.gov
September 25, 2008K082636TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3TMOSSubstantially EquivalentQuality Electrodynamicsaccessdata.fda.gov
October 31, 2007K072935SPEEDER 1.5T WRIST ARRAY COILMOSSubstantially EquivalentQuality Electrodynamicsaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
August 20, 201983775Class IITerminatedTxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.accessdata.fda.gov
July 27, 201262949Class IITerminatedTxRx 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.accessdata.fda.gov
December 29, 200851281Not yet classifiedTerminatedMirror 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.accessdata.fda.gov

Compare with other makers

Updated February 28, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.