Name: Predicase
Price: 199 USD

K-number	K230727
Device name	SPY Portable Handheld Imaging (SPY-PHI) System
Applicant	Novadaq Technologies Ulc (A Part of Stryker)
Product code	IZI
Device class	Class II
Decision date	Jun 5, 2023
Decision	Substantially Equivalent
Regulation	892.1600

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 →

SPY Portable Handheld Imaging (SPY-PHI) System

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