Harmony— 510(k) K232555

Substantially Equivalent

Topcon Healthcare Solutions

FDA 510(k) clearance K232555 for Harmony, Substantially Equivalent on 2023-11-20. Applicant: Topcon Healthcare Solutions. Device class: 2.

Clearance details

Applicant: Topcon Healthcare Solutions
Product code: Code NFJ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2023-08-23
Decision date: 2023-11-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Oakland, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NFJ

K260694 — ZEISS CLINIC 3602026-07-17
K253893 — Harmony Referral System with Harmony OCT Viewer (Octave)2026-06-04
K234076 — iCare ALTIUS CW2024-08-22
K232828 — IMAGEnet6 Ophthalmic Data System2024-03-01
K232944 — CALLISTO eye2023-12-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.