K-number	DEN190037
Device name	NaviCam Capsule Endoscope System with NaviCam Stomach Capsule
Applicant	Anx Robotica, Inc.
Product code	QKZ
Device class	Class II
Decision date	May 22, 2020
Decision	Not Substantially Equivalent
Regulation	876.1310

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 →

NaviCam Capsule Endoscope System with NaviCam Stomach Capsule

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