FDA 510(k)

PROBEAT-FR

K 號：K232032 · 2024-01-12

申請人Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

決定日期2024-01-12

產品代碼LHN

諮詢委員會RA

決定相當於

器材摘要

PROBEAT-FR is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha. It received FDA 510(k) clearance on 2024-01-12 under 510(k) number K232032. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PROBEAT-FR?

PROBEAT-FR is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha. The 510(k) number is K232032.

When did PROBEAT-FR receive FDA 510(k) clearance?

PROBEAT-FR received FDA 510(k) clearance on 2024-01-12, under 510(k) number K232032.

Who is the listed applicant for PROBEAT-FR?

The FDA 510(k) record lists Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROBEAT-FR?

The FDA product code for PROBEAT-FR is LHN.

其他以 Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha 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。

K220883小範圍應用器

相關器械（代碼：LHN）

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。

K260597VIRTUE QAProNova Solutions K260174PROBEAT-CRHitachi High-Tech Corp.K252815ProBeam 360 陽子治療系統 v3.0Varian Medical Systems, Inc.K253406S250-FIT 酸子束放射治療設備（S250-FIT）Mevion Medical Systems, Inc.K250986S250-FIT 酸子束放射治療設備（S250-FIT）Mevion Medical Systems, Inc.K243900eMotus 呼吸動態管理系統Empnia, Inc.

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。