Koios DS Breast <series 1.0>. The device is a software application which a ...



Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
Components:
Units Affected:    10
Recall Date:    Dec 31, 2019
Mfg:
Koios Medical, Inc.
Mfg Country:
United States
Recall ID:    84615
Product ID:    178820
Enforcement Date:    Jan 29, 2020
Termination Date:    May 7, 2020
Last Published:    May 7, 2020

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Emert Number:    Z-0820-2020
Emert Status:    Terminated