FDA 510(k)

RadiForce RX570；RadiForce RX570-AR

K 號：K243221 · 2024-11-27

決定日期2024-11-27

產品代碼PGY

諮詢委員會RA

決定相當於

器材摘要

RadiForce RX570; RadiForce RX570-AR is the device name listed in this FDA 510(k) record. The listed applicant is Eizo Corporation. It received FDA 510(k) clearance on 2024-11-27 under 510(k) number K243221. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RadiForce RX570; RadiForce RX570-AR?

RadiForce RX570; RadiForce RX570-AR is a medical device that received FDA 510(k) clearance on 2024-11-27. The listed applicant is Eizo Corporation. The 510(k) number is K243221.

When did RadiForce RX570; RadiForce RX570-AR receive FDA 510(k) clearance?

RadiForce RX570; RadiForce RX570-AR received FDA 510(k) clearance on 2024-11-27, under 510(k) number K243221.

Who is the listed applicant for RadiForce RX570; RadiForce RX570-AR?

FDA 510(k) 記錄中將 Eizo Corporation 列為申請人。這並不單獨確立該設備製造商。

What is the FDA product code for RadiForce RX570; RadiForce RX570-AR?

The FDA product code for RadiForce RX570; RadiForce RX570-AR is PGY.

其他以 Eizo Corporation 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。

K262397CuratOR EX2742 K262783麥迪克斯 MX247W K252030RadiForce GX570；RadiForce GX570-AR K242545麥迪森 MX317W-PA K241441RadiForce RX670；RadiForce RX670-AR K233465麥迪克斯 MX317W

查看所有 23 項裝置 →

相關器械（代碼：PGY）

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。

K262783麥迪克斯 MX247WEizo Corporation K261213醫療監視器（40HT513D）Lg Electronics.Inc K252780LCD 螢幕（CL1902A，CL2103F）Shenzhen Beacon Display Technology Co., Ltd.K253242LCD 螢幕（C1216W、C822W、C821W）Shenzhen Beacon Display Technology Co., Ltd.K252030RadiForce GX570；RadiForce GX570-AREizo Corporation K243031LCD 螢幕 C310S、G310S、C316S、G316S、C616WShenzhen Beacon Display Technology Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

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