FDA 510(k)

syngo 应用软件

K号: K254184 · 2026-04-29

决定日期2026-04-29

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

syngo Application Software is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2026-04-29 under 510(k) number K254184. 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 syngo Application Software?

syngo Application Software is a medical device that received FDA 510(k) clearance on 2026-04-29. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K254184.

When did syngo Application Software receive FDA 510(k) clearance?

syngo Application Software received FDA 510(k) clearance on 2026-04-29, under 510(k) number K254184.

Who is the listed applicant for syngo Application Software?

FDA 510(k)记录中列出西门子医疗解决方案美国公司（Siemens Medical Solutions USA, Inc.）为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for syngo Application Software?

The FDA product code for syngo Application Software is QIH.

列明Siemens Medical Solutions USA, Inc.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。

K260055syngo.CT 脑部量化 K261696ACUNAV Luxera 4D ICE 球囊导管 K260488MULTIX Impact；MULTIX Impact C K253786syngo.CT 冠状动脉驾驶舱 K253678MAMMOMAT B.brilliant (11372950)K260844ACUSON Sequoia 诊断超声系统；ACUSON Sequoia Select 诊断超声系统；ACUSON Origin 诊断超声系统；ACUSON Origin ICE 诊断超声系统

查看所有 254 个设备 →

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。