FDA 510(k)

Zap-X 放射外科系統

K 號：K171804 · 2017-09-21

決定日期2017-09-21

產品代碼IYE

諮詢委員會RA

決定相當於

器材摘要

Zap-X Radiosurgery System is the device name listed in this FDA 510(k) record. The listed applicant is Zap Surgical Systems. It received FDA 510(k) clearance on 2017-09-21 under 510(k) number K171804. 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 Radiosurgery System?

Zap-X Radiosurgery System is a medical device that received FDA 510(k) clearance on 2017-09-21. The listed applicant is Zap Surgical Systems. The 510(k) number is K171804.

When did Zap-X Radiosurgery System receive FDA 510(k) clearance?

Zap-X Radiosurgery System received FDA 510(k) clearance on 2017-09-21, under 510(k) number K171804.

Who is the listed applicant for Zap-X Radiosurgery System?

The FDA 510(k) record lists Zap Surgical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zap-X Radiosurgery System?

The FDA product code for Zap-X Radiosurgery System is IYE.

其他以 Zap Surgical Systems 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。

K183698Zap-X 放射外科系統

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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