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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Densitometer, Bone
510(k) Number K243218
Device Name TBS iNsight (V4)
Applicant
Medimaps Group SA
Chemin Du Champ-Des-Filles 36
Plan-Les-Ouates,  CH 1228
Applicant Contact Giorgio Zoia
Correspondent
Medimaps Group SA
Chemin Du Champ-Des-Filles 36
Plan-Les-Ouates,  CH 1228
Correspondent Contact Giorgio Zoia
Regulation Number892.1170
Classification Product Code
KGI  
Date Received10/04/2024
Decision Date 01/17/2025
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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