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510(k) K253893

Harmony Referral System with Harmony OCT Viewer (Octave) by Topcon Healthcare Solutions EMEA Oy — Product Code NFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2026
Date Received
December 4, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Management, Ophthalmic
Device Class
Class II
Regulation Number
892.2050
Review Panel
OP
Submission Type

Other clearances by Topcon Healthcare Solutions EMEA Oy

  • K210396 — Harmony Referral System (September 13, 2021)

Other clearances for product code NFJ

  • K234076 — iCare ALTIUS CW (August 22, 2024)
  • K232828 — IMAGEnet6 Ophthalmic Data System (March 1, 2024)
  • K232944 — CALLISTO eye (December 21, 2023)
  • K232555 — Harmony (November 20, 2023)
  • K231676 — CALLISTO eye (August 28, 2023)
  • K232088 — Altris IMS (July 31, 2023)
  • K220929 — Excelsior (October 31, 2022)
  • K213527 — FORUM (August 15, 2022)
  • K211715 — RetinAI Discovery (April 28, 2022)
  • K210396 — Harmony Referral System (September 13, 2021)