Name: Predicase
Price: 199 USD

K-number	K252000
Device name	uDR Arria & uDR Aris
Applicant	Shanghai United Imaging Healthcare Co., Ltd.
Product code	KPR
Device class	Class II
Decision date	Nov 26, 2025
Decision	Substantially Equivalent
Regulation	892.1680

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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uDR Arria & uDR Aris

Everything you need for a 510(k) submission. Nothing you don't.