FDA 510(k)

syngo.MR 应用程序（VB80）

K号: K253495 · 2025-11-20

决定日期2025-11-20

产品代码LLZ

咨询委员会RA

决定实质等同

器械摘要

syngo.MR Applications (VB80) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthineers AG. It received FDA 510(k) clearance on 2025-11-20 under 510(k) number K253495. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the syngo.MR Applications (VB80)?

syngo.MR Applications (VB80) is a medical device that received FDA 510(k) clearance on 2025-11-20. The listed applicant is Siemens Healthineers AG. The 510(k) number is K253495.

When did syngo.MR Applications (VB80) receive FDA 510(k) clearance?

syngo.MR Applications (VB80) received FDA 510(k) clearance on 2025-11-20, under 510(k) number K253495.

Who is the listed applicant for syngo.MR Applications (VB80)?

FDA 510(k)记录显示西门子医疗保健股份公司（Siemens Healthineers AG）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.MR Applications (VB80)?

The FDA product code for syngo.MR Applications (VB80) is LLZ.

列明Siemens Healthineers AG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。

K260852MAGNETOM Flow.精英；MAGNETOM Flow.尼奥；MAGNETOM Flow.崛起；MAGNETOM Flow.纯净 K253690LungMaps K253023BIOGRAPH 一号 K251059Syngo Carbon Clinicals (VA41)

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。