Cleared Traditional

uDR Arria & uDR Aris

K252000 · Shanghai United Imaging Healthcare Co., Ltd. · Radiology
Nov 2025
Decision
152d
Days
Class 2
Risk

About This 510(k) Submission

K252000 is an FDA 510(k) clearance for the uDR Arria & uDR Aris, 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 November 26, 2025, 152 days after receiving the submission on June 27, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K252000 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2025
Decision Date November 26, 2025
Days to Decision 152 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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