FDA-cleared K210791

Us2.v1

eko.ai Pte. Ltd. d/b/a Us2.ai

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2021-07-27
FDA-cleared K233676

Us2.v2

Eko.ai Pte. Ltd d/b/a Us2.ai

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2024-04-01