Harmony Referral System with Harmony OCT Viewer (Octave)— 510(k) K253893

Substantially Equivalent

Topcon Healthcare Solutions EMEA Oy

FDA 510(k) clearance K253893 for Harmony Referral System with Harmony OCT Viewer (Octave), Substantially Equivalent on 2026-06-04. Applicant: Topcon Healthcare Solutions EMEA Oy.

Clearance details

Applicant: Topcon Healthcare Solutions EMEA Oy
Product code: Code NFJ
Advisory panel: Radiology
Date received: 2025-12-04
Decision date: 2026-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oulu, FI

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