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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 K252486
Device Name ChestView US (1.1)
Applicant
Gleamer
47bis Rue Des Vinaigriers
Paris,  FR 75010
Applicant Contact Antoine Tournier
Correspondent
Gleamer
47bis Rue Des Vinaigriers
Paris,  FR 75010
Correspondent Contact Antoine Tournier
Regulation Number892.2070
Classification Product Code
MYN  
Date Received08/07/2025
Decision Date 09/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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