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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, tomography, computed
510(k) Number K212494
Device Name Lung Image Analysis
Applicant
Pulmonx Corporation
700 Chesapeake Drive
Redwood City,  CA  94063
Applicant Contact Terry Solomon
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number892.1750
Classification Product Code
JAK  
Date Received08/09/2021
Decision Date 09/02/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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