Shanghai United Imaging Intelligence Co., Ltd. radiology AI products

FDA-cleared K242292

uAI Easy Triage ICH

Shanghai United Imaging Intelligence Co., Ltd.

Assist hospital networks and trained radiologists with workflow triage by flagging and prioritizing non-enhanced head CT studies with suspected intracranial hemorrhage.

Modality: CT/CTA
Anatomy: Head/brain; intracranial hemorrhage
Decision: 2024-09-24

Stroke and ICH triage Acute triage and notification

FDA-cleared K240411

uAI Portal

Shanghai United Imaging Intelligence Co., Ltd.

uAI Portal is a software solution for viewing, manipulating, communicating, and storing medical images and for supporting interpretation and evaluation in healthcare institutions....

Modality: CT/CTA
Anatomy: Head and neck, coronary and cardiac, pulmonary arteries, lower-extremity vessels, and aorta
Decision: 2024-09-06

Cardiac imaging

FDA-cleared K222755

uMR 680

Shanghai United Imaging Intelligence Co., Ltd.

The uMR 680 is an MR diagnostic device that produces sagittal, transverse, coronal, and oblique cross-sectional images and spectroscopic images displaying internal anatomy or...

Modality: MRI
Anatomy: Head, body, and extremities
Decision: 2023-02-16

MRI workflow

FDA-cleared K193271

uAI EasyTriage-Rib

Shanghai United Imaging Intelligence Co., Ltd.

uAI EasyTriage-Rib is a radiological computer-assisted triage and notification software device for analysis of CT chest images. The device is intended to assist hospital networks...

Modality: CT/CTA
Anatomy: Chest/Lung
Decision: 2021-01-15

MSK and bone Acute triage and notification Chest CT