FDA 510(k)

Optomed Aurora 相機搭配 Aurora 视網膜模組及 Aurora 前段模組

K 號：K180378 · 2018-04-05

決定日期2018-04-05

產品代碼HKI

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

Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module is the device name listed in this FDA 510(k) record. The listed applicant is Optomed OY. It received FDA 510(k) clearance on 2018-04-05 under 510(k) number K180378. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module?

Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module is a medical device that received FDA 510(k) clearance on 2018-04-05. The listed applicant is Optomed OY. The 510(k) number is K180378.

When did Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module receive FDA 510(k) clearance?

Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module received FDA 510(k) clearance on 2018-04-05, under 510(k) number K180378.

Who is the listed applicant for Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module?

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

What is the FDA product code for Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module?

The FDA product code for Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module is HKI.

其他以 Optomed OY 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。

K163021哈格-斯特萊特眼底模組 300

相關器械（代碼：HKI）

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。

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom Technologies K252120眼底攝影手機非散瞳型 (FOP NM-10)Remidio Innovative Solutions Private Limited K250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.Ltd K250683眼底攝影機Optain Health, Inc.

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。