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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 K231917
Device Name VEA Align
Applicant
EOS imaging
10 rue Mercoeur
Paris,  FR 75011
Applicant Contact Moran Celestin
Correspondent
EOS imaging
10 rue Mercoeur
Paris,  FR 75011
Correspondent Contact Moran Celestin
Regulation Number892.2050
Classification Product Code
QIH  
Date Received06/29/2023
Decision Date 01/05/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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