SPY Portable Handheld Imaging (SPY-PHI) System

Confocal Optical Imaging

Novadaq Technologies ULC. (now A Part Of Stryker)

The following data is part of a premarket notification filed by Novadaq Technologies Ulc. (now A Part Of Stryker) with the FDA for Spy Portable Handheld Imaging (spy-phi) System.

Pre-market Notification Details

Device IDK192174
501k NumberK192174
Device Name:SPY Portable Handheld Imaging (SPY-PHI) System
ClassificationConfocal Optical Imaging
Applicant Novadaq Technologies ULC. (now A Part Of Stryker) 8329 Eastlake Drive, Unit 101 Burnaby,  CA V5a 4w2
ContactAgatha Szeliga
CorrespondentAgatha Szeliga
Novadaq Technologies ULC. (now A Part Of Stryker) 8329 Eastlake Drive, Unit 101 Burnaby,  CA V5a 4w2
Product CodeOWN  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
501k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2019-08-12
Decision Date2019-11-15

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.