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FDA 510(k)

5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR

K 號：K162497 · 2016-09-19

申請人Eizo Corporation
決定日期2016-09-19
產品代碼PGY
諮詢委員會RA
決定Substantially Equivalent

器材摘要

5MP Monochrome LCD Monitor, RadiForce GX550, GX550-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 2016-09-19 under 510(k) number K162497. 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 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR?

5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR is a medical device that received FDA 510(k) clearance on 2016-09-19. The listed applicant is Eizo Corporation. The 510(k) number is K162497.

When did 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR receive FDA 510(k) clearance?

5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR received FDA 510(k) clearance on 2016-09-19, under 510(k) number K162497.

Who is the listed applicant for 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR?

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

What is the FDA product code for 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR?

The FDA product code for 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR is PGY.

相關臨床試驗

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。

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 EX2742K262783RadiForce MX247WK252030RadiForce GX570; RadiForce GX570-ARK242545RadiForce MX317W-PAK243221RadiForce RX570; RadiForce RX570-ARK241441RadiForce RX670; RadiForce RX670-AR

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。

K262783RadiForce MX247WEizo CorporationK261213Medical Monitor (40HT513D)Lg Electronics.IncK252780LCD Monitor (CL1902A, CL2103F)Shenzhen Beacon Display Technology Co., Ltd.K253242LCD Monitor (C1216W, C822W, C821W)Shenzhen Beacon Display Technology Co., Ltd.K252030RadiForce GX570; RadiForce GX570-AREizo CorporationK243221RadiForce RX570; RadiForce RX570-AREizo Corporation

官方來源

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