FDA 510(k)

2430MCA 配合 Xmaru W

K 號：K202902 · 2021-06-21

決定日期2021-06-21

產品代碼MUE

諮詢委員會RA

決定相當於

器材摘要

2430MCA with Xmaru W is the device name listed in this FDA 510(k) record. The listed applicant is Rayence Co., Ltd.. It received FDA 510(k) clearance on 2021-06-21 under 510(k) number K202902. 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 2430MCA with Xmaru W?

2430MCA with Xmaru W is a medical device that received FDA 510(k) clearance on 2021-06-21. The listed applicant is Rayence Co., Ltd.. The 510(k) number is K202902.

When did 2430MCA with Xmaru W receive FDA 510(k) clearance?

2430MCA with Xmaru W received FDA 510(k) clearance on 2021-06-21, under 510(k) number K202902.

Who is the listed applicant for 2430MCA with Xmaru W?

FDA 510(k) 記錄將 Rayence Co., Ltd. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for 2430MCA with Xmaru W?

The FDA product code for 2430MCA with Xmaru W is MUE.

其他以 Rayence Co., Ltd. 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。

K2538000909FCE，0909FCE-HS K2438492430TCA 配合 Xmaru W K242394數位平面X光檢測器（1717WCE、1717WCE-HR、1717WCE-HS、1717WCE-GF）K2403710909FCC，0909FCC-HS K2314671417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF K220689Vatech 克里斯米爾

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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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