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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K241593
Device Name BoneMetrics (US)
Applicant
Gleamer Sas
47bis Rue Des Vinaigriers
Paris,  FR 75010
Applicant Contact Antoine Tournier
Correspondent
Gleamer Sas
47bis Rue Des Vinaigriers
Paris,  FR 75010
Correspondent Contact Antoine Tournier
Regulation Number892.2050
Classification Product Code
QIH  
Date Received06/03/2024
Decision Date 02/05/2025
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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