Name: Predicase
Price: 199 USD

K-number	K251027
Device name	cvi42 Coronary Plaque Software Application
Applicant	Circle Cardiovascular Imaging, Inc.
Product code	QIH
Device class	Class II
Decision date	Oct 27, 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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cvi42 Coronary Plaque Software Application

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