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FDA 510(k)

32Ch 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

K 號：K213687 · 2022-03-11

申請人Neocoil, LLC
決定日期2022-03-11
產品代碼MOS
諮詢委員會RA
決定相當於

器材摘要

32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch is the device name listed in this FDA 510(k) record. The listed applicant is Neocoil, LLC. It received FDA 510(k) clearance on 2022-03-11 under 510(k) number K213687. 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 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch?

32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch is a medical device that received FDA 510(k) clearance on 2022-03-11. The listed applicant is Neocoil, LLC. The 510(k) number is K213687.

When did 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch receive FDA 510(k) clearance?

32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch received FDA 510(k) clearance on 2022-03-11, under 510(k) number K213687.

Who is the listed applicant for 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch?

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 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch?

The FDA product code for 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch is MOS.

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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 CoilK22240716ch 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K2011011.5T 16ch 肩部線圈，3.0T 16ch 肩部線圈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, LLCK252587HD 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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