BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Optoacoustic Imaging System

    PMA: P200003 · Supplement: S001 · Decision Jun 17, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Optoacoustic Imaging System
    Trade Name
    Imagio® Breast Imaging system
    PMA Number
    P200003
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    QNK
    Generic Name
    Optoacoustic Imaging System
    Medical Specialty
    Unknown
    Advisory Committee
    Radiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 17, 2022
    Date Received
    November 1, 2021
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Imagio® Breast Imaging System. This device is indicated for use by a trained and qualified healthcare provider for evaluation ofpalpable and non-palpable breast abnormalities in adult patients who are referred for a diagnostic imaging breast work-up, following clinical presentation or either screening or diagnostic mammography or other imaging examinations. The ultrasound mode should be initially used in a targeted fashion, to assess any focal area(s) of clinical or imaging concerns. In ultrasound mode, the device can be used to assign a BI-RADS category to either breast tissue or a mass that is causing clinical or imaging concerns. Masses that are classified as BI-RADS categories 3 through 5 can then be assessed using the Opto-Acoustic (OA) mode. In the OA mode, the Imagio® Breast Imaging System provides information about the central nidus, boundary and peripheral zones, based on vascularity and blood oxygen saturation of the imaged tissues, to assist in thediagnosis of the benign or malignant mass(es) of interest. For ultrasound BI-RADS 3-5 masses, using the OA features of the mass allows for improved classification of the mass of interest as compared to ultrasound alone. The OA mode is not indicated for ultrasound BI- RADS 1 and 2 findings. The Imagio® Breast Imaging System includes an artificial intelligence (AI) based software function to assist the users in assessing BI-RADS classifications. This device is not intended to be used as a replacement formammographic screening or for definitive pathologic diagnosis.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QNK Optoacoustic Imaging System