Cleared Special

uMR 680

K252371 · Shanghai United Imaging Healthcare Co., Ltd. · Radiology
Sep 2025
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K252371 is an FDA 510(k) clearance for the uMR 680, a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by Shanghai United Imaging Healthcare Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on September 25, 2025, 57 days after receiving the submission on July 30, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K252371 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 2025
Decision Date September 25, 2025
Days to Decision 57 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LNH — System, Nuclear Magnetic Resonance Imaging
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1000

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