Name: Predicase
Price: 199 USD

K-number	K180461
Device name	Navi e/Navi s/Navi X Diagnostic Ultrasound System
Applicant	Shenzhen Wisonic Medical Technology Co. , Ltd.
Product code	IYN
Device class	Class II
Decision date	May 9, 2018
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 →

Navi e/Navi s/Navi X Diagnostic Ultrasound System

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