BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Myocardial Solutions

    Reg #: 3006015847 · FEI: 3006015847 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    Myocardial Solutions
    Registration Number
    3006015847
    FEI Number
    3006015847
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4819 Emperor Blvd Ste 140
    City
    Durham
    State
    NC
    ZIP
    27703
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182756

    Owner / Operator

    Firm Name
    Myocardial Solutions
    Operator Number
    10057759
    Address
    808 Aviation Parkway, Suite 700
    City
    Morrisville
    State
    NC
    Postal Code
    27560
    Country
    US
    Correspondent
    Linda J Horne

    Products

    Device Name Product Code
    System, Nuclear Magnetic Resonance Imaging LNH

    Proprietary Names

    MyoStrain MyoStrain 6

    Establishment Types

    Manufacture Medical Device