Shanghai United Imaging Intelligence Co., Ltd. FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
uAI Easy Triage ICH510(k)Sep 24, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 24, 2024
uAI Portal510(k)Sep 6, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 6, 2024
uMR 680510(k)Feb 16, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 16, 2023
uAI EasyTriage-Rib510(k)Jan 15, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 15, 2021