BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SENO MEDICAL INSTRUMENTS, INC.

    Reg #: 3014755924 · FEI: 3014755924 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    4
    Classifications
    4

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    Registration Details

    Registration Name
    SENO MEDICAL INSTRUMENTS, INC.
    Registration Number
    3014755924
    FEI Number
    3014755924
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    8023 Vantage Drive, Suite 1000
    City
    San Antonio
    State
    TX
    ZIP
    78230
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182628
    PMA Number
    P200003

    Owner / Operator

    Firm Name
    Seno Medical Instruments, Inc.
    Operator Number
    10082776
    Address
    8023 Vantage Drive, Suite 1000
    City
    San Antonio
    State
    TX
    Postal Code
    78230
    Country
    US
    Correspondent
    Ann C Waterhouse

    Products

    Device Name Product Code
    Optoacoustic Imaging System QNK
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN

    Proprietary Names

    Imagio(R) Imagio(R) Breast Imaging System Imagio Ultrasound Probe Imagio(R) US Probe

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility