Koios Medical

1 recall •

• Categories: Other Medical Devices

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

Class I - Dangerous

Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedures.

Dec 31, 2019 Other Medical Devices View Details →