FDA 510(k)

Tomey 角膜/前段斷層掃描顯微鏡 (CASIA2)

K 號：K250553 · 2025-07-18

決定日期2025-07-18

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

Tomey Cornea/Anterior Segment OCT (CASIA2) is the device name listed in this FDA 510(k) record. The listed applicant is Tomey Corporation. It received FDA 510(k) clearance on 2025-07-18 under 510(k) number K250553. 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 Tomey Cornea/Anterior Segment OCT (CASIA2)?

Tomey Cornea/Anterior Segment OCT (CASIA2) is a medical device that received FDA 510(k) clearance on 2025-07-18. The listed applicant is Tomey Corporation. The 510(k) number is K250553.

When did Tomey Cornea/Anterior Segment OCT (CASIA2) receive FDA 510(k) clearance?

Tomey Cornea/Anterior Segment OCT (CASIA2) received FDA 510(k) clearance on 2025-07-18, under 510(k) number K250553.

Who is the listed applicant for Tomey Cornea/Anterior Segment OCT (CASIA2)?

The FDA 510(k) record lists Tomey Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tomey Cornea/Anterior Segment OCT (CASIA2)?

The FDA product code for Tomey Cornea/Anterior Segment OCT (CASIA2) is OBO.

其他以 Tomey 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。

K252348東麥光學生物計 OA-2000 (OA-2000)K213265Tomey 角膜/前節部份光學斷層掃描儀 CASIA2 K171313EM-4000 光譜顯微鏡

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.K250868SPECTRALIS HRA+OCT 及其變種Heidelberg Engineering GmbH K240924AnterionHeidelberg Engineering GmbH K241163SPECTRALIS 配 Flex 模組Heidelberg Engineering GmbH

官方來源

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