K-number	K063388
Device name	TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM
Applicant	Topcon Corp.
Product code	OBO
Device class	Class II
Decision date	Jun 22, 2007
Decision	Substantially Equivalent
Regulation	886.1570

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 →

TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM

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