BEUDAMED
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    Filters Status: Terminated ×

    Koios DS Breast . The device is a software application which assists skilled physicians in analyzing breast ultrasound images.

    FDA Recall
    Terminated ·Koios Medical, Inc.·Product code LLZ·December 31, 2019

    Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.

    FDA Enforcement
    Class II ·Terminated·Koios Medical, Inc.·January 29, 2020