FDA 510(k)

Zap-X 放射外科手术系统

K号: K183698 · 2019-02-25

决定日期2019-02-25

产品代码IYE

咨询委员会RA

决定实质等同

器械摘要

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 2019-02-25 under 510(k) number K183698. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Zap-X Radiosurgery System?

Zap-X Radiosurgery System is a medical device that received FDA 510(k) clearance on 2019-02-25. The listed applicant is Zap Surgical Systems. The 510(k) number is K183698.

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

Zap-X Radiosurgery System received FDA 510(k) clearance on 2019-02-25, under 510(k) number K183698.

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.

列明Zap Surgical Systems为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K171804Zap-X 放射外科手术系统

官方来源

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