FDA 510(k)

UroNav（版本3.0）

K 號：K182561 · 2018-10-19

決定日期2018-10-19

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

UroNav (Version 3.0) is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Corporation. It received FDA 510(k) clearance on 2018-10-19 under 510(k) number K182561. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the UroNav (Version 3.0)?

UroNav (Version 3.0) is a medical device that received FDA 510(k) clearance on 2018-10-19. The listed applicant is Invivo Corporation. The 510(k) number is K182561.

When did UroNav (Version 3.0) receive FDA 510(k) clearance?

UroNav (Version 3.0) received FDA 510(k) clearance on 2018-10-19, under 510(k) number K182561.

Who is the listed applicant for UroNav (Version 3.0)?

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

What is the FDA product code for UroNav (Version 3.0)?

The FDA product code for UroNav (Version 3.0) is LLZ.

其他以 Invivo 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。

K213766dS足踝16通道線圈，適用於1.5T和3.0T，dS高解析手腕16通道線圈，適用於1.5T和3.0T，ds小型四肢16通道線圈，適用於1.5T和3.0T K212227飛利浦 MR 病患照護入口網站 K212175DynaCAD K193403UroNav 系統 K192200DynaCAD K162177dS足踝I6CH 1.5T線圈

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相關器械（代碼：LLZ）

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。

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官方來源

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