K-number	K251078
Device name	AutoDensity
Applicant	Eos Imaging
Product code	QIH
Device class	Class II
Decision date	Nov 14, 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

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AutoDensity

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