免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

TxRx 適合膝關節 15 Flare MR 緩衝環 3.0T

K 號：K163066 · 2016-11-29

申請人Quality Electrodynamics, LLC
決定日期2016-11-29
產品代碼MOS
諮詢委員會RA
決定相當於

器材摘要

TxRx Knee 15 Flare MR Coil 3.0T is the device name listed in this FDA 510(k) record. The listed applicant is Quality Electrodynamics, LLC. It received FDA 510(k) clearance on 2016-11-29 under 510(k) number K163066. 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 TxRx Knee 15 Flare MR Coil 3.0T?

TxRx Knee 15 Flare MR Coil 3.0T is a medical device that received FDA 510(k) clearance on 2016-11-29. The listed applicant is Quality Electrodynamics, LLC. The 510(k) number is K163066.

When did TxRx Knee 15 Flare MR Coil 3.0T receive FDA 510(k) clearance?

TxRx Knee 15 Flare MR Coil 3.0T received FDA 510(k) clearance on 2016-11-29, under 510(k) number K163066.

Who is the listed applicant for TxRx Knee 15 Flare MR Coil 3.0T?

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

What is the FDA product code for TxRx Knee 15 Flare MR Coil 3.0T?

The FDA product code for TxRx Knee 15 Flare MR Coil 3.0T is MOS.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Quality Electrodynamics, 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。

K242006SureWave 強度波攝影 (Q7000225)K223429輪廓膝關節K200477Flex 身體加速器K193140Flex Body 加速器K183111輪廓24K18169716ch 足/踝 SPEEDER

查看所有 14 項裝置 →

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

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。

↑