BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ATUSA™ Automated 3D Breast Ultrasound System

    K Number: K213620 · Decision Apr 22, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    348
    Registration Numbers
    349
    Same Product Code
    892
    Applicant Total
    1
    Review Days
    157

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    Basic Information

    Device Name
    ATUSA™ Automated 3D Breast Ultrasound System
    K Number
    K213620
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Isono Health, Inc.
    Date Received
    November 16, 2021
    Decision Date
    April 22, 2022
    Product Code
    IYO
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IYO System, Imaging, Pulsed Echo, Ultrasonic

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