FDA 510(k)

Synapse 3D 基础工具（V7.2）

K号: K254189 · 2026-04-30

决定日期2026-04-30

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

Synapse 3D Base Tools (V7.2) is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2026-04-30 under 510(k) number K254189. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Synapse 3D Base Tools (V7.2)?

Synapse 3D Base Tools (V7.2) is a medical device that received FDA 510(k) clearance on 2026-04-30. The listed applicant is Fujifilm Corporation. The 510(k) number is K254189.

When did Synapse 3D Base Tools (V7.2) receive FDA 510(k) clearance?

Synapse 3D Base Tools (V7.2) received FDA 510(k) clearance on 2026-04-30, under 510(k) number K254189.

Who is the listed applicant for Synapse 3D Base Tools (V7.2)?

FDA 510(k)记录中列出富士胶片公司为申请人。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 Synapse 3D Base Tools (V7.2)?

The FDA product code for Synapse 3D Base Tools (V7.2) is QIH.

列明Fujifilm 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。

K261229SCENARIA 视觉阶段 6.0 K261283APERTO 明亮 MRI 系统 K253836FCT iStream 阶段 2 K261170BA-004CC K260567EW10-EC02 内窥镜支持程序 K261880FUJIFILM 处理器 EP-8000；球囊控制器 PB-30；内窥镜支持程序 EW10-VM01

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。