PercuNav Image Fusion And Interventional Navigation

System, X-ray, Tomography, Computed

Philips Ultrasound, Inc

The following data is part of a premarket notification filed by Philips Ultrasound, Inc with the FDA for Percunav Image Fusion And Interventional Navigation.

Pre-market Notification Details

Device IDK201053
510k NumberK201053
Device Name:PercuNav Image Fusion And Interventional Navigation
ClassificationSystem, X-ray, Tomography, Computed
Applicant Philips Ultrasound, Inc 22100 Bothell Everett Highway Bothell,  WA  98021
ContactTravis Cantania
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeJAK  
Subsequent Product CodeIYO
Subsequent Product CodeLLZ
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-04-21
Decision Date2020-05-14

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