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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 Management, Ophthalmic
510(k) Number K162039
Device Name OptosAdvance 4.0 Software
Applicant
Optos Plc.
Queensferry House
Carnegie Campus, Enterprise Way
Dunfermline,  GB KY11 8GR
Applicant Contact Paul Burns
Correspondent
Hogan Lovells US LLP
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact Randy Prebula
Regulation Number892.2050
Classification Product Code
NFJ  
Date Received07/22/2016
Decision Date 02/08/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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