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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 K173390
Device Name hipEOS
Applicant
Onefit Medical
18 Rue Alain Savary
Besançon,  FR 25000
Applicant Contact Camille Vernay
Correspondent
Onefit Medical
18 Rue Alain Savary
Besançon,  FR 25000
Correspondent Contact Camille Vernay
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/30/2017
Decision Date 04/27/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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