消融系統，高強度聚焦超聲波 (HIFU)，MRI 引導
PMA 核准號：P110039 · 2018-08-16
廣告
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. It received FDA 510(k) clearance on 2018-08-16. The device is classified under product code NRZ. It was reviewed by the SU 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 2018-08-16. The listed applicant is Insightec.
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 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。
廣告