FDA 510(k)

dS守護者乳房 16通道 1.5T 緩衝器

K 號：K213735 · 2022-08-08

申請人Invivo Corporation (Business Trade Name: Philips)

決定日期2022-08-08

產品代碼MOS

諮詢委員會RA

決定相當於

器材摘要

dS Sentinelle Breast 16ch 1.5T Coil is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Corporation (Business Trade Name: Philips). It received FDA 510(k) clearance on 2022-08-08 under 510(k) number K213735. 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 dS Sentinelle Breast 16ch 1.5T Coil?

dS Sentinelle Breast 16ch 1.5T Coil is a medical device that received FDA 510(k) clearance on 2022-08-08. The listed applicant is Invivo Corporation (Business Trade Name: Philips). The 510(k) number is K213735.

When did dS Sentinelle Breast 16ch 1.5T Coil receive FDA 510(k) clearance?

dS Sentinelle Breast 16ch 1.5T Coil received FDA 510(k) clearance on 2022-08-08, under 510(k) number K213735.

Who is the listed applicant for dS Sentinelle Breast 16ch 1.5T Coil?

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

What is the FDA product code for dS Sentinelle Breast 16ch 1.5T Coil?

The FDA product code for dS Sentinelle Breast 16ch 1.5T Coil is MOS.

其他以 Invivo Corporation (Business Trade Name: Philips) 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。

K232762dS 乳房線圈 7通道 1.5T K2223258ch 腕部螺線管 K2222571.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil K213727dS守護者乳房 16通道 3.0T 緩衝器 K213351ds 頭部 32通道 3.0T

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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