BEUDAMED
    FDA Registration Active 🇺🇸 United States

    3T eCoil Imaging System Disposables (Prostate)

    Reg #: 3015431711 · FEI: 3015431711 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    DXTX MEDICAL INC.
    Registration Number
    3015431711
    FEI Number
    3015431711
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    639 Alpha Drive
    City
    Pittsburgh
    State
    PA
    ZIP
    15238
    Country
    US

    Regulatory Submissions

    510(k) Number
    K051349

    Owner / Operator

    Firm Name
    DxTx Medical Inc.
    Operator Number
    10061391
    Address
    639 Alpha Drive
    City
    Pittsburgh
    State
    PA
    Postal Code
    15238
    Country
    US
    Correspondent
    Paul Lawson

    Products

    Device Name Product Code
    Coil, Magnetic Resonance, Specialty MOS

    Proprietary Names

    3T eCoil Imaging System Disposables (Prostate)

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198