FDA-cleared K190442

Koios DS for Breast

Koios Medical, Inc.

Image analysis/processing for Breast using Mammography/DBT.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2019-07-03
FDA-cleared K212616

Koios DS

Koios Medical, Inc.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2021-12-16
FDA-cleared K242130

Koios DS

Koios Medical, Inc.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2024-11-15