FDA 510(k)

RadiForce GX570；RadiForce GX570-AR

K 號：K252030 · 2025-08-28

決定日期2025-08-28

產品代碼PGY

諮詢委員會RA

決定相當於

器材摘要

RadiForce GX570; RadiForce GX570-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 2025-08-28 under 510(k) number K252030. 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 GX570; RadiForce GX570-AR?

RadiForce GX570; RadiForce GX570-AR is a medical device that received FDA 510(k) clearance on 2025-08-28. The listed applicant is Eizo Corporation. The 510(k) number is K252030.

When did RadiForce GX570; RadiForce GX570-AR receive FDA 510(k) clearance?

RadiForce GX570; RadiForce GX570-AR received FDA 510(k) clearance on 2025-08-28, under 510(k) number K252030.

Who is the listed applicant for RadiForce GX570; RadiForce GX570-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 GX570; RadiForce GX570-AR?

The FDA product code for RadiForce GX570; RadiForce GX570-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 K242545麥迪森 MX317W-PA K243221RadiForce RX570；RadiForce RX570-AR 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.K243221RadiForce RX570；RadiForce RX570-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 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。