Name: Predicase
Price: 199 USD

K-number	K250045
Device name	uWS-Angio Pro
Applicant	Shanghai United Imaging Healthcare Co., Ltd.
Product code	LLZ
Device class	Class II
Decision date	Sep 24, 2025
Decision	Substantially Equivalent
Regulation	892.2050

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

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

uWS-Angio Pro

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