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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 K200385
Device Name CONTINUUM PACS
Applicant
Integrated Ophthalmic Systems, Inc.
596 Main Street
Woburn,  MA  01801
Applicant Contact Matthew Carnevale
Correspondent
Accelerated Device Approval Services
6800 S.W. 40th Street, Ste. 403
Ludlum,  FL  33155
Correspondent Contact Rafael Aguila
Regulation Number892.2050
Classification Product Code
NFJ  
Date Received02/18/2020
Decision Date 03/16/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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