FDA 510(k)

無線/有線X光平面探測器

K 號：K243734 · 2025-04-18

決定日期2025-04-18

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

Wireless/ Wired X-Ray Flat Panel Detectors is the device name listed in this FDA 510(k) record. The listed applicant is Allengers Medical Systems Limited. It received FDA 510(k) clearance on 2025-04-18 under 510(k) number K243734. 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 Wireless/ Wired X-Ray Flat Panel Detectors?

Wireless/ Wired X-Ray Flat Panel Detectors is a medical device that received FDA 510(k) clearance on 2025-04-18. The listed applicant is Allengers Medical Systems Limited. The 510(k) number is K243734.

When did Wireless/ Wired X-Ray Flat Panel Detectors receive FDA 510(k) clearance?

Wireless/ Wired X-Ray Flat Panel Detectors received FDA 510(k) clearance on 2025-04-18, under 510(k) number K243734.

Who is the listed applicant for Wireless/ Wired X-Ray Flat Panel Detectors?

The FDA 510(k) record lists Allengers Medical Systems Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wireless/ Wired X-Ray Flat Panel Detectors?

The FDA product code for Wireless/ Wired X-Ray Flat Panel Detectors is MQB.

其他以 Allengers Medical Systems 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。

K253296數位C-ARM搭配3D K223009無線/有線X光平面檢測器 K223060DigiX FDX K220311心血管內視鏡攝影系統 K200218數位掃描FDX K192541DigiX FDX

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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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