RadOncAI
K 號：K253050 · 2026-06-18
廣告
器材摘要
RadOncAI is the device name listed in this FDA 510(k) record. The listed applicant is Informai. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K253050. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the RadOncAI?
RadOncAI is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Informai. The 510(k) number is K253050.
When did RadOncAI receive FDA 510(k) clearance?
RadOncAI received FDA 510(k) clearance on 2026-06-18, under 510(k) number K253050.
Who is the listed applicant for RadOncAI?
The FDA 510(k) record lists Informai as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RadOncAI?
The FDA product code for RadOncAI is MUJ.
相關臨床試驗
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。
相關器械（代碼：MUJ）
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。
K260750虛擬圓錐（1.0）Varian Medical Systems, Inc.K260207多模態模擬工作空間（MM Sim）（v1.0.0）Philips Medical Systems Nederland B.V.K252784eXaSkin PlusAnatomical Geometry S.L.K253078ART.1-USSeetreat Pty, Ltd.K252304syngo.via RT影像套件 VC10Varian Medical Systems, Inc.K260308TrueFit 靜脈注射劑Adaptiiv Medical Technologies, Inc.
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
廣告