Zap-X 體外放射外科系統
K 號：K211663 · 2021-07-29
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器材摘要
Zap-X Radiosurgical System is the device name listed in this FDA 510(k) record. The listed applicant is Zap Surgical Systems, Inc.. It received FDA 510(k) clearance on 2021-07-29 under 510(k) number K211663. 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 Zap-X Radiosurgical System?
Zap-X Radiosurgical System is a medical device that received FDA 510(k) clearance on 2021-07-29. The listed applicant is Zap Surgical Systems, Inc.. The 510(k) number is K211663.
When did Zap-X Radiosurgical System receive FDA 510(k) clearance?
Zap-X Radiosurgical System received FDA 510(k) clearance on 2021-07-29, under 510(k) number K211663.
Who is the listed applicant for Zap-X Radiosurgical System?
The FDA 510(k) record lists Zap Surgical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Zap-X Radiosurgical System?
The FDA product code for Zap-X Radiosurgical System is IYE.
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。
其他以 Zap Surgical Systems, 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。
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。
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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