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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
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