FDA 510(k)

1.5T 16ch 肩部線圈，3.0T 16ch 肩部線圈

K 號：K201101 · 2020-06-02

決定日期2020-06-02

產品代碼MOS

諮詢委員會RA

決定相當於

器材摘要

1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil is the device name listed in this FDA 510(k) record. The listed applicant is Neocoil, LLC. It received FDA 510(k) clearance on 2020-06-02 under 510(k) number K201101. 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 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil?

1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil is a medical device that received FDA 510(k) clearance on 2020-06-02. The listed applicant is Neocoil, LLC. The 510(k) number is K201101.

When did 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil receive FDA 510(k) clearance?

1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil received FDA 510(k) clearance on 2020-06-02, under 510(k) number K201101.

Who is the listed applicant for 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil?

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

What is the FDA product code for 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil?

The FDA product code for 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil is MOS.

其他以 Neocoil, LLC 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。

K2609470.55T 12Ch Breast Coil K22240716ch 乳癌線圈 / 16ch 乳癌線圈，1.5T 16ch 乳癌線圈，3.0T 16ch 乳癌線圈，1.5T 16ch 乳癌線圈，3T 16ch 乳癌線圈 K21368732Ch AIR 開放式线圈套件：1.5T AIR 開放式頭頸後部 9ch / 3.0T AIR 開放式頭頸後部 9ch，1.5T AIR 開放式頸部胸部前部 7ch / 3.0T AIR 開放式頸部胸部前部 7ch，1.5T AIR 開放式頭部前部 16ch / 3.0T AIR 開放式頭部前部 16ch K1829581.5T 16ch 乳頭線圈 K173409無線音頻系統 K1733773.0T 16ch乳腺线圈

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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

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