BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DXTX MEDICAL INC.

    Reg #: 3015431711 · FEI: 3015431711 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    DXTX MEDICAL INC.
    Registration Number
    3015431711
    FEI Number
    3015431711
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    639 Alpha Drive
    City
    Pittsburgh
    State
    PA
    ZIP
    15238
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243428

    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
    Prostate Immobilizer Rectal Balloon PCT
    System, Nuclear Magnetic Resonance Imaging LNH

    Proprietary Names

    e2Coil Imaging System for the Siemens MAGNETOM 3T MRI Systems with Tim 4G Connector Pro-Tx Endorectal Balloon 1.5T eCoil Imaging System Disposables Colon 1.5 eCoil Imaging System Disposables Cervix 1.5T Imaging Device for Siemens 3T eCoil Imaging Device for GE 1.5 T eCoil Imaging System for Philips 1.5T eCoil Imaging System Disposables Prostate 1.5T eCoil Imaging Device for GE 3T eCoil Imaging System Disposables (Prostate)

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198