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FDA 510(k)

Harmony Referral System with Harmony OCT Viewer (Octave)

K-Number: K253893 · 2026-06-04

ApplicantTopcon Healthcare Solutions EMEA Oy
Decision Date2026-06-04
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Harmony Referral System with Harmony OCT Viewer (Octave) is the device name listed in this FDA 510(k) record. The listed applicant is Topcon Healthcare Solutions EMEA Oy. It received FDA 510(k) clearance on 2026-06-04 under 510(k) number K253893. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Harmony Referral System with Harmony OCT Viewer (Octave)?

Harmony Referral System with Harmony OCT Viewer (Octave) is a medical device that received FDA 510(k) clearance on 2026-06-04. The listed applicant is Topcon Healthcare Solutions EMEA Oy. The 510(k) number is K253893.

When did Harmony Referral System with Harmony OCT Viewer (Octave) receive FDA 510(k) clearance?

Harmony Referral System with Harmony OCT Viewer (Octave) received FDA 510(k) clearance on 2026-06-04, under 510(k) number K253893.

Who is the listed applicant for Harmony Referral System with Harmony OCT Viewer (Octave)?

The FDA 510(k) record lists Topcon Healthcare Solutions EMEA Oy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Harmony Referral System with Harmony OCT Viewer (Octave)?

The FDA product code for Harmony Referral System with Harmony OCT Viewer (Octave) is NFJ.

Other records listing Topcon Healthcare Solutions EMEA Oy as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210396Harmony Referral System

Related Devices (Code: NFJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260694ZEISS CLINIC 360Carl Zeiss Meditec, AGK234076iCare ALTIUS CWCentervue S.P.A.K232828IMAGEnet6 Ophthalmic Data SystemTopcon CorporationK232944CALLISTO eyeCarl Zeiss Meditec, AGK232555HarmonyTopcon Healthcare SolutionsK231676CALLISTO eyeCarl Zeiss Meditec, AG

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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