FDA 510(k)

SIGNA 電腦斷層掃描/磁共振成像設備

K 號：K213709 · 2022-01-20

決定日期2022-01-20

產品代碼OUO

諮詢委員會RA

決定相當於

器材摘要

SIGNA PET/MR is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2022-01-20 under 510(k) number K213709. 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 SIGNA PET/MR?

SIGNA PET/MR is a medical device that received FDA 510(k) clearance on 2022-01-20. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K213709.

When did SIGNA PET/MR receive FDA 510(k) clearance?

SIGNA PET/MR received FDA 510(k) clearance on 2022-01-20, under 510(k) number K213709.

Who is the listed applicant for SIGNA PET/MR?

The FDA 510(k) record lists Ge Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIGNA PET/MR?

The FDA product code for SIGNA PET/MR is OUO.

其他以 Ge Medical Systems, LLC 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：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.K253023BIOGRAPH 一Siemens Healthineers AG K234154uPMR 790Shanghai United Imaging Healthcare Co., Ltd.K222540uPMR 790Shanghai United Imaging Healthcare Co., Ltd.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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