Name: Predicase
Price: 199 USD

K-number	K984280
Device name	AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE
Applicant	Hitachi Medical Systems America, Inc.
Product code	LNH
Device class	Class II
Decision date	Feb 8, 1999
Decision	Substantially Equivalent
Regulation	892.1000

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 →

AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE

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