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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 K172346
Device Name sterEOS Workstation
Applicant
EOS imaging
10 rue Mercoeur
Paris,  FR 75011
Applicant Contact Mathias Breuil
Correspondent
EOS imaging
10 rue Mercoeur
Paris,  FR 75011
Correspondent Contact Mathias Breuil
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/03/2017
Decision Date 06/19/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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