FDA-cleared K242130

Koios DS

Koios Medical, Inc.

Koios Decision Support (DS) is an artificial intelligence (AI)/machine learning (ML)-based computer-aided diagnosis (CADx) software device intended for use as an adjunct to...

Modality
Ultrasound
Anatomy
Breast
Decision
2024-11-15
FDA-cleared K212616

Koios DS

Koios Medical, Inc.

Koios DS is an artificial intelligence (AI)/machine learning (ML)-based computer-aided diagnosis (CADx) software device intended for use as an adjunct to diagnostic ultrasound...

Modality
Ultrasound
Anatomy
Breast
Decision
2021-12-16
FDA-cleared K190442

Koios DS for Breast

Koios Medical, Inc.

Adjunctive breast-cancer decision support during diagnostic ultrasound for patients referred for further diagnostic ultrasound; classifies a user-selected lesion ROI into four...

Modality
Mammography/DBT
Anatomy
Soft-tissue breast lesions.
Decision
2019-07-03