FDA 510(k)

BIOGRAPH 一

K 號：K253023 · 2026-01-15

決定日期2026-01-15

產品代碼OUO

諮詢委員會RA

決定相當於

器材摘要

BIOGRAPH One 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 2026-01-15 under 510(k) number K253023. The device is classified under product code OUO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BIOGRAPH One?

BIOGRAPH One is a medical device that received FDA 510(k) clearance on 2026-01-15. The listed applicant is Siemens Healthineers AG. The 510(k) number is K253023.

When did BIOGRAPH One receive FDA 510(k) clearance?

BIOGRAPH One received FDA 510(k) clearance on 2026-01-15, under 510(k) number K253023.

Who is the listed applicant for BIOGRAPH One?

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 BIOGRAPH One?

The FDA product code for BIOGRAPH One is OUO.

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。

K260852MAGNETOM Flow.精英；MAGNETOM Flow.尼奧；MAGNETOM Flow.昇；MAGNETOM Flow.純 K253690肺地圖 K253495syngo.MR 應用程序（VB80）K251059Syngo碳臨床 (VA41)

相關器械（代碼：OUO）

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。

K253963Cubresa 大腦正子斷層掃描儀Cubresa, Inc.K234154uPMR 790Shanghai United Imaging Healthcare Co., Ltd.K222540uPMR 790Shanghai United Imaging Healthcare Co., Ltd.K213709SIGNA 電腦斷層掃描/磁共振成像設備Ge Medical Systems, LLC K200213Biograph mMR 配合 syngo MR E11P-AP01 系統軟體Siemens Medical Solutions USA, Inc.K192672uPMR 790Shanghai United Imaging Healthcare Co., Ltd.

官方來源

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