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FDA 510(k)

Advanced Algorithms for Treatment Management Applications (AATMA)

K 號：K212218 · 2021-10-25

申請人Elekta Solutions AB
決定日期2021-10-25
產品代碼QKB
諮詢委員會RA
決定相當於

器材摘要

Advanced Algorithms for Treatment Management Applications (AATMA) is the device name listed in this FDA 510(k) record. The listed applicant is Elekta Solutions AB. It received FDA 510(k) clearance on 2021-10-25 under 510(k) number K212218. 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 Advanced Algorithms for Treatment Management Applications (AATMA)?

Advanced Algorithms for Treatment Management Applications (AATMA) is a medical device that received FDA 510(k) clearance on 2021-10-25. The listed applicant is Elekta Solutions AB. The 510(k) number is K212218.

When did Advanced Algorithms for Treatment Management Applications (AATMA) receive FDA 510(k) clearance?

Advanced Algorithms for Treatment Management Applications (AATMA) received FDA 510(k) clearance on 2021-10-25, under 510(k) number K212218.

Who is the listed applicant for Advanced Algorithms for Treatment Management Applications (AATMA)?

FDA 510(k) 記錄將 Elekta Solutions AB 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Advanced Algorithms for Treatment Management Applications (AATMA)?

The FDA product code for Advanced Algorithms for Treatment Management Applications (AATMA) is QKB.

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Elekta Solutions AB 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。

K261932萊克塞爾® Vantage 積極定位系統K252002Monaco RTP系統（6.3）K252188EMLA (Elekta Evo)；EMLA (VersaHD)；EMLA (Elekta Harmony Pro)；EMLA (Elekta Infintiy)；EMLA (Elekta Harmony)；EMLA (Elekta Synergy)K251363ProKnow DSK250391萊克塞爾伽馬刀® (Elekta Esprit)；萊克塞爾伽馬刀® (Icon™)；萊克塞爾伽馬刀® (Perfexion™)K232854萊克塞爾伽馬計劃（LGP）

查看所有 15 項裝置 →

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 SystemsK260528OncoStudioOncosoft. Inc.,K252548AI-Rad Companion 器官 RTSiemens Healthcare GmbHK252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.K253270Contour ProtégéAI+Mim Software, Inc.

官方來源

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