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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 K132438
Device Name IMAGENET 5 PC SOFTWARE SYSTEM
Applicant
Topcon Medical Systems, Inc.
5 Timber Ln.
North Reading,  MA  01864
Applicant Contact MAUREEN O'CONNELL
Correspondent
Topcon Medical Systems, Inc.
5 Timber Ln.
North Reading,  MA  01864
Correspondent Contact MAUREEN O'CONNELL
Regulation Number892.2050
Classification Product Code
NFJ  
Date Received08/05/2013
Decision Date 10/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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