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FDA-cleared K242292

uAI Easy Triage ICH

Shanghai United Imaging Intelligence Co., Ltd.

Authorized purpose: 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
FDA-cleared K240411

uAI Portal

Shanghai United Imaging Intelligence Co., Ltd.

Authorized purpose: uAI Portal is a software solution for viewing, manipulating, communicating, and storing medical images and for supporting interpretation and evaluation in healthcare institutions. The FDA material describes lower-extremity vessel, head-and-neck vessel, coronary, pulmonary-artery, and aorta analysis functions for the corresponding CT angiography studies.

Modality
CT/CTA
Anatomy
Head and neck, coronary and cardiac, pulmonary arteries, lower-extremity vessels, and aorta
Decision
2024-09-06
FDA-cleared K222755

uMR 680

Shanghai United Imaging Intelligence Co., Ltd.

Authorized purpose: 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 function of the head, body, and extremities; physical parameters derived from the images may assist diagnosis when interpreted by a trained physician, and contrast agents may be used depending on the region.

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