FDA 510(k)

Contour ProtégéAI+

K 號：K253270 · 2026-03-27

決定日期2026-03-27

產品代碼QKB

諮詢委員會RA

決定相當於

器材摘要

Contour ProtégéAI+ is the device name listed in this FDA 510(k) record. The listed applicant is Mim Software, Inc.. It received FDA 510(k) clearance on 2026-03-27 under 510(k) number K253270. 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 Contour ProtégéAI+?

Contour ProtégéAI+ is a medical device that received FDA 510(k) clearance on 2026-03-27. The listed applicant is Mim Software, Inc.. The 510(k) number is K253270.

When did Contour ProtégéAI+ receive FDA 510(k) clearance?

Contour ProtégéAI+ received FDA 510(k) clearance on 2026-03-27, under 510(k) number K253270.

Who is the listed applicant for Contour ProtégéAI+?

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

What is the FDA product code for Contour ProtégéAI+?

The FDA product code for Contour ProtégéAI+ is QKB.

其他以 Mim Software, 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。

K251883MIM – 準確病變識別系統 Pro K250035Contour ProtégéAI+K243012MIM – 和弦HDR融合 K233620MIM - 百分位數等級量表 K232862MIM – 蒙特卡羅劑量學 K232514MIM – 剂量分析

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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 K260509AutoContour (RADAC V5)Radformation, Inc.

官方來源

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