FDA 510(k)

Syngo碳臨床 (VA41)

K 號：K251059 · 2025-10-24

決定日期2025-10-24

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

Syngo Carbon Clinicals (VA41) 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 2025-10-24 under 510(k) number K251059. 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 Carbon Clinicals (VA41)?

Syngo Carbon Clinicals (VA41) is a medical device that received FDA 510(k) clearance on 2025-10-24. The listed applicant is Siemens Healthineers AG. The 510(k) number is K251059.

When did Syngo Carbon Clinicals (VA41) receive FDA 510(k) clearance?

Syngo Carbon Clinicals (VA41) received FDA 510(k) clearance on 2025-10-24, under 510(k) number K251059.

Who is the listed applicant for Syngo Carbon Clinicals (VA41)?

FDA 510(k) 記錄中將西门子健康儀器公司（Siemens Healthineers AG）列為申請人。這並不單獨確立該設備製造商的身份。

What is the FDA product code for Syngo Carbon Clinicals (VA41)?

The FDA product code for Syngo Carbon Clinicals (VA41) is QIH.

其他以 Siemens Healthineers AG 為申請人之記錄

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。

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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。

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官方來源

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