FDA 510(k)

HistoSonics®規劃工具

K 號：K252947 · 2026-05-29

決定日期2026-05-29

產品代碼QTZ

諮詢委員會RA

決定相當於

器材摘要

HistoSonics® Planning Tool is the device name listed in this FDA 510(k) record. The listed applicant is HistoSonics, Inc.. It received FDA 510(k) clearance on 2026-05-29 under 510(k) number K252947. The device is classified under product code QTZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HistoSonics® Planning Tool?

HistoSonics® Planning Tool is a medical device that received FDA 510(k) clearance on 2026-05-29. The listed applicant is HistoSonics, Inc.. The 510(k) number is K252947.

When did HistoSonics® Planning Tool receive FDA 510(k) clearance?

HistoSonics® Planning Tool received FDA 510(k) clearance on 2026-05-29, under 510(k) number K252947.

Who is the listed applicant for HistoSonics® Planning Tool?

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

What is the FDA product code for HistoSonics® Planning Tool?

The FDA product code for HistoSonics® Planning Tool is QTZ.

其他以 HistoSonics, Inc. 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。

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相關器械（代碼：QTZ）

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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