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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 K253893
Device Name Harmony Referral System with Harmony OCT Viewer (Octave)
Applicant
Topcon Healthcare Solutions EMEA Oy
Saaristonkatu 9
Oulu,  FI 90100
Applicant Contact Tobias Schwarz
Correspondent
Topcon Healthcare, Inc.
111 Bauer Dr.
Oakland,  NJ  07436
Correspondent Contact Ian Boland
Regulation Number892.2050
Classification Product Code
NFJ  
Date Received12/04/2025
Decision Date 06/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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