FDA 510(k)

小範圍應用器

K 號：K220883 · 2022-12-15

申請人Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

決定日期2022-12-15

產品代碼LHN

諮詢委員會RA

決定相當於

器材摘要

Small Field Applicator 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 2022-12-15 under 510(k) number K220883. 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 Small Field Applicator?

Small Field Applicator is a medical device that received FDA 510(k) clearance on 2022-12-15. The listed applicant is Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha. The 510(k) number is K220883.

When did Small Field Applicator receive FDA 510(k) clearance?

Small Field Applicator received FDA 510(k) clearance on 2022-12-15, under 510(k) number K220883.

Who is the listed applicant for Small Field Applicator?

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 Small Field Applicator?

The FDA product code for Small Field Applicator 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。

K232032PROBEAT-FR

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。

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官方來源

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