FDA 510(k)

syngo.CT Brain Quantification

K号: K260055 · 2026-09-25

决定日期2026-09-25

产品代码QIH

咨询委员会RA

决定Substantially Equivalent

器械摘要

syngo.CT Brain Quantification 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 2026-09-25 under 510(k) number K260055. 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.CT Brain Quantification?

syngo.CT Brain Quantification is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K260055.

When did syngo.CT Brain Quantification receive FDA 510(k) clearance?

syngo.CT Brain Quantification received FDA 510(k) clearance on 2026-09-25, under 510(k) number K260055.

Who is the listed applicant for syngo.CT Brain Quantification?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for syngo.CT Brain Quantification?

The FDA product code for syngo.CT Brain Quantification 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。

K261696ACUNAV Luxera 4D ICE Catheter K260488MULTIX Impact; MULTIX Impact C K253786syngo.CT Coronary Cockpit 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 K261315Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 系列

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