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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 K261289
Device Name UNiD™ Spine Analyzer (SW3002)
Applicant
Medicrea International S.A.S. (Medtronic)
5389 Rte. De Strasbourg - Vancia
Rillieux-La-Pape,  FR 69140
Applicant Contact Hajar BOULMAN
Correspondent
Medicrea International S.A.S. (Medtronic)
5389 Rte. De Strasbourg - Vancia
Rillieux-La-Pape,  FR 69140
Correspondent Contact Hajar BOULMAN
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received04/20/2026
Decision Date 05/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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