FDA 510(k)

syngo Dynamics (VA41F)

K 號：K253689 · 2026-04-10

決定日期2026-04-10

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

syngo Dynamics (VA41F) 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 2026-04-10 under 510(k) number K253689. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the syngo Dynamics (VA41F)?

syngo Dynamics (VA41F) is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is Siemens Healthcare GmbH. The 510(k) number is K253689.

When did syngo Dynamics (VA41F) receive FDA 510(k) clearance?

syngo Dynamics (VA41F) received FDA 510(k) clearance on 2026-04-10, under 510(k) number K253689.

Who is the listed applicant for syngo Dynamics (VA41F)?

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 syngo Dynamics (VA41F)?

The FDA product code for syngo Dynamics (VA41F) is QIH.

其他以 Siemens Healthcare GmbH 為申請人之記錄

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K253264我的消融導引器（VC10A）K252548AI-Rad Companion 器官 RT K253057AI-Rad Companion 腦部 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 K250443MAGNETOM Avanto Fit；MAGNETOM Skyra Fit；MAGNETOM Sola Fit；MAGNETOM Viato.Mobile

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相關器械（代碼：QIH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260055syngo.CT 脑量化Siemens Medical Solutions USA, Inc.K262390骨專家Visiana K261368快速平台（R6.7）Ischemaview, Inc.K261623EchoPAC 軟體僅 / EchoPAC 插件（v211）GE Medical Systems Ultrasound and Primary Care Diagnostics K261677人工智慧腎臟評估（AIRA）版本 1Aramis Global AI Consultancies, LLC K2608794DMINVIA, LLC

官方來源

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