FDA 510(k)

3D光學相干斷層掃描（3D OCT-1（型號：Maestro2））

K 號：K233561 · 2024-04-10

決定日期2024-04-10

產品代碼OBO

諮詢委員會此為醫療器材法規文本之翻譯。根據醫療法規翻譯政策，以下為繁體中文譯文：本文件概述適用於醫療器材之監管架構，包括美國食品藥物管理局（FDA）之上市前審查程序。第510(k)條途徑適用於與已合法上市器材（predicate device）實質等效之器材，而上市前核准（PMA）則為最高風險等級（Class III）器材所要求。臨床證據可能引用NCT編號之試驗登記，或PMID編號之同行評審文獻。所有產品名稱、公司名稱、識別碼及統一資源定位符（URL）均保留原文，以確保可追溯性及法規提交之完整性。

決定相當於

器材摘要

3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) is the device name listed in this FDA 510(k) record. The listed applicant is Topcon Corporation. It received FDA 510(k) clearance on 2024-04-10 under 510(k) number K233561. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))?

3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) is a medical device that received FDA 510(k) clearance on 2024-04-10. The listed applicant is Topcon Corporation. The 510(k) number is K233561.

When did 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) receive FDA 510(k) clearance?

3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) received FDA 510(k) clearance on 2024-04-10, under 510(k) number K233561.

Who is the listed applicant for 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))?

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 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))?

The FDA product code for 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) is OBO.

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 K232828IMAGEnet6 眼科數據系統 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

查看所有 12 項裝置 →

相關器械（代碼：OBO）

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。

K261019安特里昂Heidelberg Engineering GmbH K253837SPECTRALIS HRA+OCT 及其變種；配備 Flex 模組的 SPECTRALISHeidelberg Engineering GmbH K252633UNITY DX (UDX)Cylite Pty. , Ltd.K250553Tomey 角膜/前段斷層掃描顯微鏡 (CASIA2)Tomey Corporation K250868SPECTRALIS HRA+OCT 及其變種Heidelberg Engineering GmbH K240924AnterionHeidelberg Engineering GmbH

官方來源

在 FDA 資料庫中查看 →

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。