FDA 510(k)

AutoContour Model RADAC V2

K 號：K220598 · 2022-08-24

決定日期2022-08-24

產品代碼QKB

諮詢委員會RA

決定相當於

器材摘要

AutoContour Model RADAC V2 is the device name listed in this FDA 510(k) record. The listed applicant is Radformation, Inc.. It received FDA 510(k) clearance on 2022-08-24 under 510(k) number K220598. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AutoContour Model RADAC V2?

AutoContour Model RADAC V2 is a medical device that received FDA 510(k) clearance on 2022-08-24. The listed applicant is Radformation, Inc.. The 510(k) number is K220598.

When did AutoContour Model RADAC V2 receive FDA 510(k) clearance?

AutoContour Model RADAC V2 received FDA 510(k) clearance on 2022-08-24, under 510(k) number K220598.

Who is the listed applicant for AutoContour Model RADAC V2?

FDA 510(k) 記錄將 Radformation, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for AutoContour Model RADAC V2?

The FDA product code for AutoContour Model RADAC V2 is QKB.

其他以 Radformation, 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。

K261718EZFluence (RADEZ V2)K262452AutoContour (RADAC V6)K253962ClearCheck (RADCC V2.7)K260509AutoContour (RADAC V5)K252988ChartCheck (RADCH V1.6)K252863ClearCalc 模型 RADCA V2.6

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相關器械（代碼：QKB）

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。

K262452AutoContour (RADAC V6)Radformation, Inc.K261306AI Contouring (VA10A)Varian Medical Systems K260528OncoStudioOncosoft. Inc.,K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.K252548AI-Rad Companion 器官 RTSiemens Healthcare GmbH K253270Contour ProtégéAI+Mim Software, Inc.

官方來源

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