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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 K180091
Device Name UNiD Spine Analyzer
Applicant
Medicrea International
5389 Route de Strasbourg- Vancia
Rillieux La Pape,  FR 69140
Applicant Contact David Ryan
Correspondent
Medicrea International
5389 Route de Strasbourg- Vancia
Rillieux La Pape,  FR 69140
Correspondent Contact David Ryan
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/12/2018
Decision Date 02/08/2018
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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