FDA 510(k)

IMAGEnet6 眼科數據系統

K 號：K232828 · 2024-03-01

決定日期2024-03-01

產品代碼NFJ

諮詢委員會RA

決定相當於

器材摘要

IMAGEnet6 Ophthalmic Data System is the device name listed in this FDA 510(k) record. The listed applicant is Topcon Corporation. It received FDA 510(k) clearance on 2024-03-01 under 510(k) number K232828. 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 IMAGEnet6 Ophthalmic Data System?

IMAGEnet6 Ophthalmic Data System is a medical device that received FDA 510(k) clearance on 2024-03-01. The listed applicant is Topcon Corporation. The 510(k) number is K232828.

When did IMAGEnet6 Ophthalmic Data System receive FDA 510(k) clearance?

IMAGEnet6 Ophthalmic Data System received FDA 510(k) clearance on 2024-03-01, under 510(k) number K232828.

Who is the listed applicant for IMAGEnet6 Ophthalmic Data System?

FDA 510(k) 記錄中將 Topcon Corporation 列為申請人。這並不單獨確立該設備製造商。

What is the FDA product code for IMAGEnet6 Ophthalmic Data System?

The FDA product code for IMAGEnet6 Ophthalmic Data System is NFJ.

其他以 Topcon Corporation 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。

K262637鼻用裂隙燈 SL-D4（型號：LED）K253039AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA K2410813D光學相干斷層掃描3D OCT-1（型號：Maestro2）；IMAGEnet6眼科數據系統 K2335613D光學相干斷層掃描（3D OCT-1（型號：Maestro2））K2312223D光學相干斷層掃描3D OCT-1（型號：Maestro2）K221111非散瞳眼底攝影機 NW500

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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 K253893Harmony參考系統搭配Harmony OCT檢視器（Octave）Topcon Healthcare Solutions EMEA Oy K234076iCare ALTIUS CWCentervue S.P.A.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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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。