Back to free search
Home / Search / K061608

MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER

Hitachi Medical Corp. · Class II · Cleared Nov 22, 2006

K-numberK061608
Device nameMODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER
ApplicantHitachi Medical Corp.
Product codeIYN
Device classClass II
Decision dateNov 22, 2006
DecisionSubstantially Equivalent
Regulation892.1550
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 →

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 →