K-number	DEN230043
Device name	Notal Vision Home Optical Coherence Tomography (OCT) System
Applicant	Notal Vision, Inc.
Product code	SAX
Device class	Class II
Decision date	May 15, 2024
Decision	Not Substantially Equivalent
Regulation	886.1600

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 →

Notal Vision Home Optical Coherence Tomography (OCT) System

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