Lung Image Analysis

System, X-ray, Tomography, Computed

Pulmonx Corporation

The following data is part of a premarket notification filed by Pulmonx Corporation with the FDA for Lung Image Analysis.

Pre-market Notification Details

Device IDK212494
510k NumberK212494
Device Name:Lung Image Analysis
ClassificationSystem, X-ray, Tomography, Computed
Applicant Pulmonx Corporation 700 Chesapeake Drive Redwood City,  CA  94063
ContactTerry Solomon
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2021-08-09
Decision Date2021-09-02

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