FDA 510(k)

Harmony推荐系统与Harmony OCT查看器（Octave）

K号: K253893 · 2026-06-04

决定日期2026-06-04

产品代码NFJ

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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.

列明Topcon Healthcare Solutions EMEA Oy为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K210396Harmony推荐系统

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。