K-number	DEN220063
Device name	Caption Interpretation Automated Ejection Fraction Software
Applicant	Caption Health, Inc.
Product code	QVD
Device class	Class II
Decision date	Feb 24, 2023
Decision	Not Substantially Equivalent
Regulation	892.2055

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

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 →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

Caption Interpretation Automated Ejection Fraction Software

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