K-number	K190989
Device name	6400 Ultrasound System (MyLabX6, MyLabX7)
Applicant	Esaote, S.p.A.
Product code	IYN
Device class	Class II
Decision date	May 10, 2019
Decision	Substantially Equivalent
Regulation	892.1550

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 →

6400 Ultrasound System (MyLabX6, MyLabX7)

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