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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 K220758
Device Name e-Ortho Shoulder Software v1.1
Applicant
FH Industrie
Zi De Kernevez-6 Rue Nobel
Quimper Finistere,  FR 29000
Applicant Contact Oscar Ramirez
Correspondent
MRC Global, LLC
9085 E. Mineral Cir., Suite 110
Centennial,,  CO  80112
Correspondent Contact Dawn N. Norman
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/15/2022
Decision Date 09/30/2022
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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