BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Hyperfine, Inc

    Reg #: 3014310698 · FEI: 3014310698 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    5

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    Registration Details

    Registration Name
    Hyperfine, Inc
    Registration Number
    3014310698
    FEI Number
    3014310698
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    351 New Whitfield Street
    City
    Guilford
    State
    CT
    ZIP
    06437
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223268

    Owner / Operator

    Firm Name
    Hyperfine, Inc.
    Operator Number
    10077154
    Address
    351 New Whitfield St
    City
    Guilford
    State
    CT
    Postal Code
    06437
    Country
    US
    Correspondent
    Robert Fasciano

    Products

    Device Name Product Code
    Automated Radiological Image Processing Software QIH
    Cradle, Patient, Radiologic KXH
    System, Nuclear Magnetic Resonance Imaging LNH
    Coil, Magnetic Resonance, Specialty MOS
    Holder, Head, Radiographic IWY

    Proprietary Names

    BrainInsight Back Cushion Swoop Portable MR Imaging System Foam Had Pad Head Stabilizer

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device