FDA 510(k)

RefleXion醫療放射治療系統

K 號：K190978 · 2020-03-12

決定日期2020-03-12

產品代碼IYE

諮詢委員會RA

決定相當於

器材摘要

RefleXion Medical Radiotherapy System 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 2020-03-12 under 510(k) number K190978. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RefleXion Medical Radiotherapy System?

RefleXion Medical Radiotherapy System is a medical device that received FDA 510(k) clearance on 2020-03-12. The listed applicant is Reflexion Medical, Inc.. The 510(k) number is K190978.

When did RefleXion Medical Radiotherapy System receive FDA 510(k) clearance?

RefleXion Medical Radiotherapy System received FDA 510(k) clearance on 2020-03-12, under 510(k) number K190978.

Who is the listed applicant for RefleXion Medical Radiotherapy System?

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?

The FDA product code for RefleXion Medical Radiotherapy System is IYE.

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。

K252071RefleXion醫療放射治療系統，RefleXion X2

相關器械（代碼：IYE）

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。

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官方來源

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