FDA 510(k)

ZAP-X 放射外科系統 (ZAP-X)

K 號：K250392 · 2025-11-03

決定日期2025-11-03

產品代碼IYE

諮詢委員會RA

決定相當於

器材摘要

ZAP-X Radiosurgery System (ZAP-X) 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 2025-11-03 under 510(k) number K250392. 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)?

ZAP-X Radiosurgery System (ZAP-X) is a medical device that received FDA 510(k) clearance on 2025-11-03. The listed applicant is Zap Surgical Systems, Inc.. The 510(k) number is K250392.

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

ZAP-X Radiosurgery System (ZAP-X) received FDA 510(k) clearance on 2025-11-03, under 510(k) number K250392.

Who is the listed applicant for ZAP-X Radiosurgery System (ZAP-X)?

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 Radiosurgery System (ZAP-X)?

The FDA product code for ZAP-X Radiosurgery System (ZAP-X) is IYE.

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。

K211663Zap-X 體外放射外科系統

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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