RefleXion醫療放射治療系統，RefleXion X2
K 號：K252071 · 2025-12-18
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器材摘要
RefleXion Medical Radiotherapy System, Reflexion X2 is the device name listed in this FDA 510(k) record. The listed applicant is Reflexion Medical, Inc.. It received FDA 510(k) clearance on 2025-12-18 under 510(k) number K252071. The device is classified under product code QVA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the RefleXion Medical Radiotherapy System, Reflexion X2?
RefleXion Medical Radiotherapy System, Reflexion X2 is a medical device that received FDA 510(k) clearance on 2025-12-18. The listed applicant is Reflexion Medical, Inc.. The 510(k) number is K252071.
When did RefleXion Medical Radiotherapy System, Reflexion X2 receive FDA 510(k) clearance?
RefleXion Medical Radiotherapy System, Reflexion X2 received FDA 510(k) clearance on 2025-12-18, under 510(k) number K252071.
Who is the listed applicant for RefleXion Medical Radiotherapy System, Reflexion X2?
The FDA 510(k) record lists Reflexion Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RefleXion Medical Radiotherapy System, Reflexion X2?
The FDA product code for RefleXion Medical Radiotherapy System, Reflexion X2 is QVA.
相關臨床試驗
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其他以 Reflexion Medical, 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。
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。
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