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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K261500
Device Name KBA3D (v2.4.0)
Applicant
S.M.A.I.O
2, Pl. Berthe Morisot
Saint-Priest,  FR 69800
Applicant Contact Jean-Charles Roussouly
Correspondent
BioVera, Inc.
65 Promenade Saint Louis
Notre-Dame-De-L’Ile-Perrot,  CA J7W3J6
Correspondent Contact Robert A Poggie
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/06/2026
Decision Date 08/17/2026
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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