FDA 510(k)

Harmony參考系統搭配Harmony OCT檢視器（Octave）

K 號：K253893 · 2026-06-04

決定日期2026-06-04

產品代碼NFJ

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

其他以 Topcon Healthcare Solutions EMEA Oy 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K210396和諧參考系統

相關器械（代碼：NFJ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260694蔡司臨床360Carl Zeiss Meditec, AG K234076iCare ALTIUS CWCentervue S.P.A.K232828IMAGEnet6 眼科數據系統Topcon Corporation K232944卡利斯多眼鏡Carl Zeiss Meditec, AG K232555和諧Topcon Healthcare Solutions K231676卡利斯多眼鏡Carl Zeiss Meditec, AG

官方來源

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