FDA 510(k)

Lux HD 35 检測器（Lux HD 35）；Lux HD 43 检測器（Lux HD 43）

K 號：K243556 · 2025-03-18

申請人Iray Imaging Technology (Haining) Limited

決定日期2025-03-18

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) is the device name listed in this FDA 510(k) record. The listed applicant is Iray Imaging Technology (Haining) Limited. It received FDA 510(k) clearance on 2025-03-18 under 510(k) number K243556. 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 Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)?

Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) is a medical device that received FDA 510(k) clearance on 2025-03-18. The listed applicant is Iray Imaging Technology (Haining) Limited. The 510(k) number is K243556.

When did Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) receive FDA 510(k) clearance?

Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) received FDA 510(k) clearance on 2025-03-18, under 510(k) number K243556.

Who is the listed applicant for Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)?

The FDA 510(k) record lists Iray Imaging Technology (Haining) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)?

The FDA product code for Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) is MQB.

其他以 Iray Imaging Technology (Haining) Limited 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。

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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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