FDA 510(k)

e2Coil™ 開放式成像系統，適用於西门子 MAGNETOM 3.0T MRI 系統，配備 Tim 4G 接頭

K 號：K243428 · 2025-07-17

決定日期2025-07-17

產品代碼MOS

諮詢委員會RA

決定相當於

器材摘要

e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector is the device name listed in this FDA 510(k) record. The listed applicant is Dxtx Medical, Inc.. It received FDA 510(k) clearance on 2025-07-17 under 510(k) number K243428. 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 e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector?

e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector is a medical device that received FDA 510(k) clearance on 2025-07-17. The listed applicant is Dxtx Medical, Inc.. The 510(k) number is K243428.

When did e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector receive FDA 510(k) clearance?

e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector received FDA 510(k) clearance on 2025-07-17, under 510(k) number K243428.

Who is the listed applicant for e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector?

The FDA 510(k) record lists Dxtx Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector?

The FDA product code for e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector is MOS.

其他以 Dxtx Medical, Inc. 為申請人之記錄

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K223249Pro-Tx 直腸氣球 (PROT-25)

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。

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