FDA 510(k)

MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile

K号: K250443 · 2025-06-16

决定日期2025-06-16

产品代码LNH

咨询委员会RA

决定实质等同

器械摘要

MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare GmbH. It received FDA 510(k) clearance on 2025-06-16 under 510(k) number K250443. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile?

MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile is a medical device that received FDA 510(k) clearance on 2025-06-16. The listed applicant is Siemens Healthcare GmbH. The 510(k) number is K250443.

When did MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile receive FDA 510(k) clearance?

MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile received FDA 510(k) clearance on 2025-06-16, under 510(k) number K250443.

Who is the listed applicant for MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile?

The FDA 510(k) record lists Siemens Healthcare GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile?

The FDA product code for MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile is LNH.

列明Siemens Healthcare GmbH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。

K253264我的消融指南（VC10A）K253689syngo Dynamics (VA41F)K252548AI-Rad Companion器官实时放疗 K253057AI-Rad Companion脑部MRI K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise K252608AI-Rad Companion前列腺MRI

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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。