FDA 510(k)

數位平面X光檢測器（1717WCE、1717WCE-HR、1717WCE-HS、1717WCE-GF）

K 號：K242394 · 2024-09-09

決定日期2024-09-09

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) 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 2024-09-09 under 510(k) number K242394. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)?

Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) is a medical device that received FDA 510(k) clearance on 2024-09-09. The listed applicant is Rayence Co., Ltd.. The 510(k) number is K242394.

When did Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) receive FDA 510(k) clearance?

Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) received FDA 510(k) clearance on 2024-09-09, under 510(k) number K242394.

Who is the listed applicant for Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)?

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 Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)?

The FDA product code for Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) is MQB.

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 K2403710909FCC，0909FCC-HS K2314671417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF K220689Vatech 克里斯米爾 K2127530909FCB，1212FCA

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相關器械（代碼：MQB）

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-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996通用1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530偵測器（Lux HD 2530）Iray Imaging Technology (Haining) Limited K250211玉山X光平面面板檢測器Innocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

官方來源

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