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Sources: EU EUDAMED, US FDA
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Koios Medical, Inc.
FDA registration
Koios Medical, Inc.·3 products·🇺🇸 United States
Koios DS
FDA UDI
KOIOS MEDICAL, INC.·00860002545714·Koios Decision Support (DS) is a software appli...
Koios Medical
FDA UDI
KOIOS MEDICAL, INC.·00860002545707·The Koios DS Breast system is designed to assis...
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