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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer Assisted Detection/Diagnosis Software For Fracture
510(k) Number K222176
Device Name BoneView
Applicant
Gleamer
5 Avenue du Général de Gaulle
Saint Mandé,  FR 94160
Applicant Contact Antoine Tournier
Correspondent
Gleamer
5 Avenue du Général de Gaulle
Saint Mandé,  FR 94160
Correspondent Contact Antoine Tournier
Classification Product Code
QBS  
Date Received07/22/2022
Decision Date 03/02/2023
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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