FDA-cleared K193271

uAI EasyTriage-Rib

Shanghai United Imaging Intelligence Co., Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2021-01-15
FDA-cleared K222755

uMR 680

Shanghai United Imaging Intelligence Co., Ltd.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2023-02-16
FDA-cleared K240411

uAI Portal

Shanghai United Imaging Intelligence Co., Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-09-06
FDA-cleared K242292

uAI Easy Triage ICH

Shanghai United Imaging Intelligence Co., Ltd.

Image analysis/processing for Brain using CT/CTA.

Modality
CT/CTA
Anatomy
Brain
Decision
2024-09-24