FDA 510(k)

EVAC-MRI

K 號：K252514 · 2025-11-05

決定日期2025-11-05

產品代碼JXG

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定Unknown

器材摘要

EVAC-MRI is the device name listed in this FDA 510(k) record. The listed applicant is Phasor Health, LLC. It received FDA 510(k) clearance on 2025-11-05 under 510(k) number K252514. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Unknown.

常見問題

What is the EVAC-MRI?

EVAC-MRI is a medical device that received FDA 510(k) clearance on 2025-11-05. The listed applicant is Phasor Health, LLC. The 510(k) number is K252514.

When did EVAC-MRI receive FDA 510(k) clearance?

EVAC-MRI received FDA 510(k) clearance on 2025-11-05, under 510(k) number K252514.

Who is the listed applicant for EVAC-MRI?

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

What is the FDA product code for EVAC-MRI?

The FDA product code for EVAC-MRI is JXG.

其他以 Phasor Health, 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。

K252696遺留設備名稱醫療設備規範文本 (保留公司/產品名稱、FDA、510(k)、PMA、NCT、PMID、識別符和網址) 政策：醫療規範-v1 返回僅翻譯內容 LEGACY K252060綠色 K250505EZ-FIDUCIALS K243205EVAC

相關器械（代碼：JXG）

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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官方來源

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