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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 K141922
Device Name IRIS INTELLIGENT RETINAL IMAGING SYSTEM
Applicant
INTELLIGENT RETINAL IMAGING SYSTEMS, LLC
300 BRICKSTONE SQUARE
ANDOVER,  MA  01810
Applicant Contact RYAN BOUCHARD
Correspondent
INTELLIGENT RETINAL IMAGING SYSTEMS, LLC
300 BRICKSTONE SQUARE
ANDOVER,  MA  01810
Correspondent Contact RYAN BOUCHARD
Regulation Number892.2050
Classification Product Code
NFJ  
Date Received07/16/2014
Decision Date 02/27/2015
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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