FDA 510(k)

NanoZoomer S360MD 切片扫描系统

K号: K213883 · 2022-09-27

决定日期2022-09-27

产品代码PSY

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决定实质等同

器械摘要

NanoZoomer S360MD Slide scanner system is the device name listed in this FDA 510(k) record. The listed applicant is Hamamatsu Photonics K.K.. It received FDA 510(k) clearance on 2022-09-27 under 510(k) number K213883. The device is classified under product code PSY. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NanoZoomer S360MD Slide scanner system?

NanoZoomer S360MD Slide scanner system is a medical device that received FDA 510(k) clearance on 2022-09-27. The listed applicant is Hamamatsu Photonics K.K.. The 510(k) number is K213883.

When did NanoZoomer S360MD Slide scanner system receive FDA 510(k) clearance?

NanoZoomer S360MD Slide scanner system received FDA 510(k) clearance on 2022-09-27, under 510(k) number K213883.

Who is the listed applicant for NanoZoomer S360MD Slide scanner system?

FDA 510(k)记录中列出Hamamatsu Photonics K.K.为申请人。这本身并不足以确立该设备的制造商。

What is the FDA product code for NanoZoomer S360MD Slide scanner system?

The FDA product code for NanoZoomer S360MD Slide scanner system is PSY.

列明Hamamatsu Photonics K.K.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。

K260964NanoZoomer S540MD 显微玻片扫描系统 K253606NanoZoomer S20MD 显微玻片扫描系统；NanoZoomer S360MD 显微玻片扫描系统 K233027NanoZoomer S360MD 切片扫描系统 K162117NIRO-200NX DP

官方来源

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