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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 K251747
Device Name VEA Align; spineEOS
Applicant
EOS imaging
32 rue blanche
Paris,  FR 75009
Applicant Contact Mathilde Masurel
Correspondent
EOS imaging
32 rue blanche
Paris,  FR 75009
Correspondent Contact Mathilde Masurel
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received06/06/2025
Decision Date 08/15/2025
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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