FDA 510(k)

1.5T 和 3.0T 16 CH GE 肩部線圈

K 號：K162001 · 2016-08-31

決定日期2016-08-31

產品代碼MOS

諮詢委員會RA

決定相當於

器材摘要

1.5T and 3.0T 16 CH GE Shoulder Coils is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Corporation. It received FDA 510(k) clearance on 2016-08-31 under 510(k) number K162001. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 1.5T and 3.0T 16 CH GE Shoulder Coils?

1.5T and 3.0T 16 CH GE Shoulder Coils is a medical device that received FDA 510(k) clearance on 2016-08-31. The listed applicant is Invivo Corporation. The 510(k) number is K162001.

When did 1.5T and 3.0T 16 CH GE Shoulder Coils receive FDA 510(k) clearance?

1.5T and 3.0T 16 CH GE Shoulder Coils received FDA 510(k) clearance on 2016-08-31, under 510(k) number K162001.

Who is the listed applicant for 1.5T and 3.0T 16 CH GE Shoulder Coils?

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 1.5T and 3.0T 16 CH GE Shoulder Coils?

The FDA product code for 1.5T and 3.0T 16 CH GE Shoulder Coils is MOS.

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 K182561UroNav（版本3.0）

查看所有 8 項裝置 →

相關器械（代碼：MOS）

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。

K262330dS乳頭 7ch 1.5TdS乳頭 7ch 3.0TdS乳頭 16ch 1.5TdS乳頭 16ch 3.0TdS乳頭線圈 7ch 1.5TdS Sentinelle乳頭 16ch 1.5TdS Sentinelle乳頭 16ch 3.0TPhilips Medical Systems Nederland B.V.K262294dS足踝16通道1.5T；dS足踝16通道3.0T；dS高解析手/腕16通道1.5T；dS高解析手/腕16CH 3.0T；dS小型 extremity 16通道1.5T；dS小型 extremity 16通道3.0TPhilips Medical Systems Nederland B.V.K2609470.55T 12Ch Breast CoilNeocoil, LLC K252587HD 8通道手腕陣列Shenzhen RF Tech Co., Ltd.K252876GEM Flex 線圈 16-L 阵列，3.0T 接收僅；GEM Flex 線圈 16-M 阵列，3.0T 接收僅；GEM Flex 線圈 16-S 阵列，3.0T 接收僅Shenzhen RF Tech Co., Ltd.K260519Smart Fit 躯幹心臟 1.5TPhilips Healthcare (Suzhou) Co., Ltd.

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。