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FDA 510(k)

和諧

K 號：K182376 · 2018-09-28

申請人Topcon Medical Systems, Inc.
決定日期2018-09-28
產品代碼NFJ
諮詢委員會RA
決定相當於

器材摘要

Harmony is the device name listed in this FDA 510(k) record. The listed applicant is Topcon Medical Systems, Inc.. It received FDA 510(k) clearance on 2018-09-28 under 510(k) number K182376. 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?

Harmony is a medical device that received FDA 510(k) clearance on 2018-09-28. The listed applicant is Topcon Medical Systems, Inc.. The 510(k) number is K182376.

When did Harmony receive FDA 510(k) clearance?

Harmony received FDA 510(k) clearance on 2018-09-28, under 510(k) number K182376.

Who is the listed applicant for Harmony?

The FDA 510(k) record lists Topcon Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Harmony?

The FDA product code for Harmony is NFJ.

相關臨床試驗

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NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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, AGK253893Harmony參考系統搭配Harmony OCT檢視器（Octave）Topcon Healthcare Solutions EMEA OyK234076iCare ALTIUS CWCentervue S.P.A.K232828IMAGEnet6 眼科數據系統Topcon CorporationK232944卡利斯多眼鏡Carl Zeiss Meditec, AGK232555和諧Topcon Healthcare Solutions

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