FDA 510(k)

QOCA®影像智慧RT輪廓系統

K 號：K231855 · 2024-02-13

決定日期2024-02-13

產品代碼QKB

諮詢委員會RA

決定相當於

器材摘要

QOCA® image Smart RT Contouring System is the device name listed in this FDA 510(k) record. The listed applicant is Quanta Computer, Inc.. It received FDA 510(k) clearance on 2024-02-13 under 510(k) number K231855. 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 QOCA® image Smart RT Contouring System?

QOCA® image Smart RT Contouring System is a medical device that received FDA 510(k) clearance on 2024-02-13. The listed applicant is Quanta Computer, Inc.. The 510(k) number is K231855.

When did QOCA® image Smart RT Contouring System receive FDA 510(k) clearance?

QOCA® image Smart RT Contouring System received FDA 510(k) clearance on 2024-02-13, under 510(k) number K231855.

Who is the listed applicant for QOCA® image Smart RT Contouring System?

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

What is the FDA product code for QOCA® image Smart RT Contouring System?

The FDA product code for QOCA® image Smart RT Contouring System is QKB.

其他以 Quanta Computer, 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。

K221868QOCA影像智慧CXR影像處理系統 K210179QOCA 隨身心電圖監測設備

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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