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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 K171370
Device Name IMAGEnet 6 Ophthalmic Data System
Topcon Corporation
75-1 Hasunuma-Cho, Itabashi-Ku
Tokyo,  JP 174-8580
Applicant Contact James Lorkowski
O'Connell Regulatory Consultants, Inc.
5 Timber Lane
North Reading,  MA  01864
Correspondent Contact Maureen O'Connell
Regulation Number892.2050
Classification Product Code
Subsequent Product Codes
Date Received05/10/2017
Decision Date 11/01/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls