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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 K181016
Device Name Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System
Applicant
Welch Allyn, Inc.
4341 State St. Rd.
Skaneateles Falls,  NY  13153
Applicant Contact Megan Pellenz
Correspondent
Welch Allyn, Inc.
4341 State St. Rd.
Skaneateles Falls,  NY  13153
Correspondent Contact Megan Pellenz
Regulation Number892.2050
Classification Product Code
NFJ  
Date Received04/17/2018
Decision Date 07/16/2018
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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