FDA 510(k)

玉山X光平面面板檢測器

K 號：K191939 · 2019-08-29

決定日期2019-08-29

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

Yushan X-Ray Flat Panel Detector is the device name listed in this FDA 510(k) record. The listed applicant is Innocare Optoelectronics Corp.. It received FDA 510(k) clearance on 2019-08-29 under 510(k) number K191939. 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 Yushan X-Ray Flat Panel Detector?

Yushan X-Ray Flat Panel Detector is a medical device that received FDA 510(k) clearance on 2019-08-29. The listed applicant is Innocare Optoelectronics Corp.. The 510(k) number is K191939.

When did Yushan X-Ray Flat Panel Detector receive FDA 510(k) clearance?

Yushan X-Ray Flat Panel Detector received FDA 510(k) clearance on 2019-08-29, under 510(k) number K191939.

Who is the listed applicant for Yushan X-Ray Flat Panel Detector?

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

What is the FDA product code for Yushan X-Ray Flat Panel Detector?

The FDA product code for Yushan X-Ray Flat Panel Detector is MQB.

其他以 Innocare Optoelectronics Corp. 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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