Name: Predicase
Price: 199 USD

K-number	K251004
Device name	Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)
Applicant	Hefei Chimed Intelligent Machine Co., Ltd.
Product code	OXO
Device class	Class II
Decision date	Nov 6, 2025
Decision	Substantially Equivalent
Regulation	892.1650

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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Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)

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