FDA.report

510(k) K230727

Device
SPY Portable Handheld Imaging (SPY-PHI) System
Applicant
Novadaq Technologies Ulc (A Part of Stryker)
510(k) number
K230727
Product code
IZI
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-05
Date received
2023-03-16
Regulation
892.1600
Classification name
System, X-Ray, Angiographic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Cara Cahill
Address
8329 Eastlake Dr. Unit 101 Burnaby CA V5A 4W2 V5A 4W2

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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K181537GLOW800Leica Microsystems (Schweiz) AG2018-09-07
K180019CAAS WorkstationPie Medical Imaging BV2018-05-03
K162991YELLOW 560 Fluorescence ModuleCarl Zeiss Meditec, AG2017-07-24