導向式聚焦超聲系統
PMA 核准號：P150038 · 2026-09-16
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器材摘要
MR-guided focused ultrasound system is the device name listed in this FDA 510(k) record. The listed applicant is Insightec. It received FDA 510(k) clearance on 2026-09-16. The device is classified under product code POH. It was reviewed by the NE advisory panel.
常見問題
What is the MR-guided focused ultrasound system?
MR-guided focused ultrasound system is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is Insightec.
When did MR-guided focused ultrasound system receive FDA 510(k) clearance?
The clearance date for MR-guided focused ultrasound system can be found in the official FDA records.
誰是列出的MR導向聚焦超聲系統申請人？
The FDA 510(k) record lists Insightec as the applicant. This does not by itself establish the device manufacturer.
FDA產品代碼是什麼？MR導向聚焦超聲系統？
FDA產品代碼為MR導向聚焦超聲系統的是POH。
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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