FDA 510(k)

1.5T 直腸內線圈，3.0T 直腸內線圈，ER 線圈支撐

K 號：K191539 · 2020-01-31

決定日期2020-01-31

產品代碼MOS

諮詢委員會RA

決定相當於

器材摘要

1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Biomedical GmbH. It received FDA 510(k) clearance on 2020-01-31 under 510(k) number K191539. 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 Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support?

1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support is a medical device that received FDA 510(k) clearance on 2020-01-31. The listed applicant is Rapid Biomedical GmbH. The 510(k) number is K191539.

When did 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support receive FDA 510(k) clearance?

1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support received FDA 510(k) clearance on 2020-01-31, under 510(k) number K191539.

Who is the listed applicant for 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support?

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

What is the FDA product code for 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support?

The FDA product code for 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support is MOS.

其他以 Rapid Biomedical 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。

K21348031P/1H 頭线圈，23Na/1H 頭线圈，13C/1H 頭线圈 K1819481.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil K163661P-140-Flex 絲圈，Na-140-Flex 絲圈，C-140-Flex 絲圈

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。