K-number	K955387
Device name	ISOTRON III, ISOTRON IV
Applicant	Excel Tech. , Ltd.
Product code	LIH
Device class	Class II
Decision date	Mar 22, 1996
Decision	Substantially Equivalent for Some Indications
Regulation	882.5890

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 →

ISOTRON III, ISOTRON IV

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