Cleared Traditional

Lung Image Analysis

K212494 · Pulmonx Corporation · Radiology
Sep 2021
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K212494 is an FDA 510(k) clearance for the Lung Image Analysis, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Pulmonx Corporation (Redwood Citry, US). The FDA issued a Cleared decision on September 2, 2021, 24 days after receiving the submission on August 9, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K212494 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2021
Decision Date September 02, 2021
Days to Decision 24 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAK — System, X-ray, Tomography, Computed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750

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