Name: Predicase
Price: 199 USD

K-number	K250288
Device name	TeraRecon Cardiovascular.Calcification.CT
Applicant	Terarecon,Inc.
Product code	QIH
Device class	Class II
Decision date	Oct 23, 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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TeraRecon Cardiovascular.Calcification.CT

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