FDA 510(k)

IMAGEnet 6 眼科數據系統

K 號：K171370 · 2017-11-01

決定日期2017-11-01

產品代碼NFJ

諮詢委員會RA

決定相當於

器材摘要

IMAGEnet 6 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 2017-11-01 under 510(k) number K171370. 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 IMAGEnet 6 Ophthalmic Data System?

IMAGEnet 6 Ophthalmic Data System is a medical device that received FDA 510(k) clearance on 2017-11-01. The listed applicant is Topcon Corporation. The 510(k) number is K171370.

When did IMAGEnet 6 Ophthalmic Data System receive FDA 510(k) clearance?

IMAGEnet 6 Ophthalmic Data System received FDA 510(k) clearance on 2017-11-01, under 510(k) number K171370.

Who is the listed applicant for IMAGEnet 6 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 IMAGEnet 6 Ophthalmic Data System?

The FDA product code for IMAGEnet 6 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））K232828IMAGEnet6 眼科數據系統 K2312223D光學相干斷層掃描3D OCT-1（型號：Maestro2）

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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.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

官方來源

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