Cleared Traditional

uCT 780 with uWS-CT-Dual Energy Analysis

K253173 · Shanghai United Imaging Healthcare Co., Ltd. · Radiology
Jan 2026
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K253173 is an FDA 510(k) clearance for the uCT 780 with uWS-CT-Dual Energy Analysis, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Shanghai United Imaging Healthcare Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on January 20, 2026, 116 days after receiving the submission on September 26, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K253173 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2025
Decision Date January 20, 2026
Days to Decision 116 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAK — System, X-ray, Tomography, Computed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750

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