Back to free search
Home / Search / K051920

VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001

Volcano Corporation · Class II · Cleared Aug 19, 2005

K-numberK051920
Device nameVOLCANO S5 IMAGING SYSTEM, MODEL 804200-001
ApplicantVolcano Corporation
Product codeIYO
Device classClass II
Decision dateAug 19, 2005
DecisionSubstantially Equivalent
Regulation892.1560
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 →

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

14-day free trial. No setup. Cancel anytime.

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 →