Cleared Traditional

uWS-Angio Pro

K250045 · Shanghai United Imaging Healthcare Co., Ltd. · Radiology
Sep 2025
Decision
257d
Days
Class 2
Risk

About This 510(k) Submission

K250045 is an FDA 510(k) clearance for the uWS-Angio Pro, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Shanghai United Imaging Healthcare Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on September 24, 2025, 257 days after receiving the submission on January 10, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K250045 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 2025
Decision Date September 24, 2025
Days to Decision 257 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050