消融系統，高強度聚焦超聲波 (HIFU)，MRI 引導
PMA 核准號：P040003 · 2025-07-23
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決定日期2025-07-23
PMA 編號P040003
產品代碼NRZ
器械分類3 類
醫療專科U
諮詢委員會OB設備之醫療設備規範文本翻譯如下：
關於OB設備的醫療設備規範文件：
此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：
識別碼：[識別碼]
網址：[網址]
政策：醫療規範-v1
器材摘要
Ablation system, high intensity focused ultrasound (HIFU), MR-guided is the device name listed in this FDA 510(k) record. The listed applicant is Insightec, Ltd.. It received FDA 510(k) clearance on 2025-07-23. The device is classified under product code NRZ. It was reviewed by the OB advisory panel.
常見問題
What is the Ablation system, high intensity focused ultrasound (HIFU), MR-guided?
Ablation system, high intensity focused ultrasound (HIFU), MR-guided is a medical device that received FDA 510(k) clearance on 2025-07-23. The listed applicant is Insightec, Ltd..
When did Ablation system, high intensity focused ultrasound (HIFU), MR-guided receive FDA 510(k) clearance?
The clearance date for Ablation system, high intensity focused ultrasound (HIFU), MR-guided can be found in the official FDA records.
Who is the listed applicant for Ablation system, high intensity focused ultrasound (HIFU), MR-guided?
The FDA 510(k) record lists Insightec, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ablation system, high intensity focused ultrasound (HIFU), MR-guided?
The FDA product code for Ablation system, high intensity focused ultrasound (HIFU), MR-guided is NRZ.
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。
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。
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