BEUDAMED
    FDA Registration Active 🇺🇸 United States

    QUALITY ELECTRODYNAMICS

    Reg #: 3007350713 · FEI: 3007350713 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    54
    Establishment Types
    5
    Classifications
    5

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    Registration Details

    Registration Name
    QUALITY ELECTRODYNAMICS
    Registration Number
    3007350713
    FEI Number
    3007350713
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6655 Beta Drive Suite 100
    City
    Mayfield Village
    State
    OH
    ZIP
    44143
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233656

    Owner / Operator

    Firm Name
    Quality Electrodynamics
    Operator Number
    10023379
    Address
    6655 Beta Drive, Suite 100
    City
    Mayfield Village
    State
    OH
    Postal Code
    44143
    Country
    US
    Correspondent
    Kathleen Aras

    Products

    Device Name Product Code
    Coil, Magnetic Resonance, Specialty MOS
    System, Nuclear Magnetic Resonance Imaging LNH
    System, Nuclear Magnetic Resonance Spectroscopic LNI
    Instrument, Quality-Assurance, Radiologic LHO
    Accelerator, Linear, Medical IYE

    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 32ch Head SPEEDER Coil Atlas SPEEDER Head/Neck SureWave Elastography 32ch Cardiac SPEEDER Coil 18ch T/R Knee Coil Extra Large Knee SPEEDER Coil (Tx/Rx) Head-Neck Coil Medium Torso Coil 8ch Knee-Foot SPEEDER Contour Knee 16ch TxRx Knee SPEEDER Breast SPEEDER CX Grid Holder CX Breast Riser CX TxRx Knee 15 Flare MR Coil 1.5T T/R QD Head Coil Shoulder SPEEDER Coil Tx/Rx Extra Large Knee Coil Siemens 3T 1H/13C TXRX Loop Siemens 3T 1H/23NA TXRX CP Head Coil Siemens 3T 1H/19F TXRX CP Head Siemens 3T 1H/23NA TXRX Loop Siemens 3T 1H/31P TXRX Loop Siemens 3T 1H/19F TXRX Loop Siemens 3T 1H/13C TXRX CP Head Siemens 3T 1H/31P TXRX CP Head Contour Hand/Wrist 16 ch TxRx Knee SPEEDER Atlas SPEEDER Body Atlas SPEEDER Head Atlas SPEEDER Spine QD Head Wrist SPEEDER Shoulder SPEEDER Atlas SPEEDER Head-Neck Coil Pediatric 16 Pediatric Cradle Wrist SPEEDER Coil

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Device in the United States for Export Only