Cleared Traditional

uDR Aurora CX

K251167 · Shanghai United Imaging Healthcare Co., Ltd. · Radiology
Sep 2025
Decision
157d
Days
Class 2
Risk

About This 510(k) Submission

K251167 is an FDA 510(k) clearance for the uDR Aurora CX, a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by Shanghai United Imaging Healthcare Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on September 19, 2025, 157 days after receiving the submission on April 15, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K251167 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2025
Decision Date September 19, 2025
Days to Decision 157 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPR — System, X-ray, Stationary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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