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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Medical Image
510(k) Number K243239
Device Name Lung AI (LAI001)
Applicant
Exo, Inc.
4201 Burton Dr.
Santa Clara,  CA  95054
Applicant Contact Murray Jacqueline
Correspondent
Exo, Inc.
4201 Burton Dr.
Santa Clara,  CA  95054
Correspondent Contact Jacqueline Murray
Regulation Number892.2070
Classification Product Code
MYN  
Date Received10/10/2024
Decision Date 04/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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