FDA 510(k)

森諾格拉芙普里斯蒂娜

K 號：K211725 · 2021-08-06

決定日期2021-08-06

產品代碼MUE

諮詢委員會RA

決定相當於

器材摘要

Senographe Pristina is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2021-08-06 under 510(k) number K211725. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Senographe Pristina?

Senographe Pristina is a medical device that received FDA 510(k) clearance on 2021-08-06. The listed applicant is GE Healthcare. The 510(k) number is K211725.

When did Senographe Pristina receive FDA 510(k) clearance?

Senographe Pristina received FDA 510(k) clearance on 2021-08-06, under 510(k) number K211725.

Who is the listed applicant for Senographe Pristina?

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

What is the FDA product code for Senographe Pristina?

The FDA product code for Senographe Pristina is MUE.

其他以 GE Healthcare 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：MUE）

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。

K254090I-View®Hologic, Inc.K253678MAMMOMAT B.閃耀 (11372950)Siemens Medical Solutions USA, Inc.K254092貝拉倫2D (VDMS-1000S)Vieworks Co., Ltd.K260087森諾格拉法Pristina；森諾亮HD；Pristina Serena；Pristina Serena亮GE Medical Systems SCS K243420赫西亞Genoray Co., Ltd.K2438492430TCA 配合 Xmaru WRayence Co., Ltd.

官方來源

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