FDA 510(k)

Hybrid Viewer (00859873006240)

K号: K252477 · 2025-09-09

决定日期2025-09-09

产品代码KPS

咨询委员会RA

决定实质等同

器械摘要

Hybrid Viewer (00859873006240) is the device name listed in this FDA 510(k) record. The listed applicant is Hermes Medical Solutions AB. It received FDA 510(k) clearance on 2025-09-09 under 510(k) number K252477. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Hybrid Viewer (00859873006240)?

Hybrid Viewer (00859873006240) is a medical device that received FDA 510(k) clearance on 2025-09-09. The listed applicant is Hermes Medical Solutions AB. The 510(k) number is K252477.

When did Hybrid Viewer (00859873006240) receive FDA 510(k) clearance?

Hybrid Viewer (00859873006240) received FDA 510(k) clearance on 2025-09-09, under 510(k) number K252477.

Who is the listed applicant for Hybrid Viewer (00859873006240)?

FDA 510(k)记录显示Hermes Medical Solutions AB为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Hybrid Viewer (00859873006240)?

The FDA product code for Hybrid Viewer (00859873006240) is KPS.

列明Hermes Medical Solutions AB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。

K253835Affinity K243919体素剂量学（00859873006226）K241364Hybrid Viewer (00859873006189)K202882Affinity K193152Affinity K191216Voxel剂量测量™ v1.0

查看所有 13 个设备 →

相关器械（代码：KPS）

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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