FDA 510(k)

通用DR 1748

K 號：K214030 · 2022-01-21

申請人Konica Minolta Healthcare Americas, Inc.

決定日期2022-01-21

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

Universal DR 1748 is the device name listed in this FDA 510(k) record. The listed applicant is Konica Minolta Healthcare Americas, Inc.. It received FDA 510(k) clearance on 2022-01-21 under 510(k) number K214030. 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 Universal DR 1748?

Universal DR 1748 is a medical device that received FDA 510(k) clearance on 2022-01-21. The listed applicant is Konica Minolta Healthcare Americas, Inc.. The 510(k) number is K214030.

When did Universal DR 1748 receive FDA 510(k) clearance?

Universal DR 1748 received FDA 510(k) clearance on 2022-01-21, under 510(k) number K214030.

Who is the listed applicant for Universal DR 1748?

The FDA 510(k) record lists Konica Minolta Healthcare Americas, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Universal DR 1748?

The FDA product code for Universal DR 1748 is MQB.

其他以 Konica Minolta Healthcare Americas, Inc. 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。

K252996通用1417PI K221853OTC DDR K214012直臂DDR K203743EXA K193225KDR AU-DDR系統先進U臂搭配動態數位X光攝影，KDR AU系統先進U臂搭配靜態數位X光攝影

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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