FDA 510(k)

VHA 放射治療濃縮劑

K 號：K222639 · 2022-11-04

決定日期2022-11-04

產品代碼IXI

諮詢委員會RA

決定相當於

器材摘要

VHA Radiotherapy Bolus is the device name listed in this FDA 510(k) record. The listed applicant is Vha Dean. It received FDA 510(k) clearance on 2022-11-04 under 510(k) number K222639. The device is classified under product code IXI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VHA Radiotherapy Bolus?

VHA Radiotherapy Bolus is a medical device that received FDA 510(k) clearance on 2022-11-04. The listed applicant is Vha Dean. The 510(k) number is K222639.

When did VHA Radiotherapy Bolus receive FDA 510(k) clearance?

VHA Radiotherapy Bolus received FDA 510(k) clearance on 2022-11-04, under 510(k) number K222639.

Who is the listed applicant for VHA Radiotherapy Bolus?

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

What is the FDA product code for VHA Radiotherapy Bolus?

The FDA product code for VHA Radiotherapy Bolus is IXI.

其他以 Vha Dean 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。

K220648OMF ASP 系統

相關器械（代碼：IXI）

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。

K253025麗科3D醫療輔助劑Ricoh 3D For Healthcare, LLC K214093VSP 靜脈注射劑3D Systems

官方來源

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