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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 K251629
Device Name UNiD™ Spine Analyzer
Applicant
Medicrea International S.A.S. (Medtronic)
5389 Route De Strasbourg - Vancia
Rillieux-La-Pape,  FR 69140
Applicant Contact Cecile Humbert
Correspondent
Medicrea International S.A.S. (Medtronic)
5389 Route De Strasbourg - Vancia
Rillieux-La-Pape,  FR 69140
Correspondent Contact Cecile Humbert
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received05/28/2025
Decision Date 08/07/2025
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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