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FDA 510(k)

RadiForce GX570; RadiForce GX570-AR

K号: K252030 · 2025-08-28

决定日期2025-08-28
产品代码PGY
咨询委员会RA
决定实质等同

器械摘要

RadiForce GX570; RadiForce GX570-AR is the device name listed in this FDA 510(k) record. The listed applicant is Eizo Corporation. It received FDA 510(k) clearance on 2025-08-28 under 510(k) number K252030. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RadiForce GX570; RadiForce GX570-AR?

RadiForce GX570; RadiForce GX570-AR is a medical device that received FDA 510(k) clearance on 2025-08-28. The listed applicant is Eizo Corporation. The 510(k) number is K252030.

When did RadiForce GX570; RadiForce GX570-AR receive FDA 510(k) clearance?

RadiForce GX570; RadiForce GX570-AR received FDA 510(k) clearance on 2025-08-28, under 510(k) number K252030.

Who is the listed applicant for RadiForce GX570; RadiForce GX570-AR?

FDA 510(k)记录中列出Eizo Corporation为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for RadiForce GX570; RadiForce GX570-AR?

The FDA product code for RadiForce GX570; RadiForce GX570-AR is PGY.

相关临床试验

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。

列明Eizo Corporation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。

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相关器械(代码:PGY)

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。

官方来源

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