FDA 510(k)

乳房BI 7 MR 線圈 1.5T Mammavention

K 號：K180123 · 2018-02-16

決定日期2018-02-16

產品代碼MOS

諮詢委員會RA

決定相當於

器材摘要

Breast BI 7 MR Coil 1.5T Mammavention is the device name listed in this FDA 510(k) record. The listed applicant is Noras Mri Products GmbH. It received FDA 510(k) clearance on 2018-02-16 under 510(k) number K180123. 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 Breast BI 7 MR Coil 1.5T Mammavention?

Breast BI 7 MR Coil 1.5T Mammavention is a medical device that received FDA 510(k) clearance on 2018-02-16. The listed applicant is Noras Mri Products GmbH. The 510(k) number is K180123.

When did Breast BI 7 MR Coil 1.5T Mammavention receive FDA 510(k) clearance?

Breast BI 7 MR Coil 1.5T Mammavention received FDA 510(k) clearance on 2018-02-16, under 510(k) number K180123.

Who is the listed applicant for Breast BI 7 MR Coil 1.5T Mammavention?

The FDA 510(k) record lists Noras Mri Products GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Breast BI 7 MR Coil 1.5T Mammavention?

The FDA product code for Breast BI 7 MR Coil 1.5T Mammavention is MOS.

其他以 Noras Mri Products GmbH 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。

K241069iLoop介入電線圈 0.55T K220144乳房BI環組 0.55T；乳房BI 7 MR環組 1.5T；乳房BI 7 MR環組 3T K211658OR頭架 LUCY 配 HeadCoilSet 西門子 1.5T，OR頭架 LUCY 配 HeadCoilSet 西門子 3T，OR頭架 LUCY 配 HeadCoilSet 飛利浦 1.5T，OR頭架 LUCY 配 HeadCoilSet 飛利浦 3T

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.

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