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FDA 510(k)

平面面板檢測器

K 號：K201591 · 2020-09-03

申請人Ka Imaging, Inc.
決定日期2020-09-03
產品代碼MQB
諮詢委員會RA
決定相當於

器材摘要

Flat Panel Detector is the device name listed in this FDA 510(k) record. The listed applicant is Ka Imaging, Inc.. It received FDA 510(k) clearance on 2020-09-03 under 510(k) number K201591. 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 Flat Panel Detector?

Flat Panel Detector is a medical device that received FDA 510(k) clearance on 2020-09-03. The listed applicant is Ka Imaging, Inc.. The 510(k) number is K201591.

When did Flat Panel Detector receive FDA 510(k) clearance?

Flat Panel Detector received FDA 510(k) clearance on 2020-09-03, under 510(k) number K201591.

Who is the listed applicant for Flat Panel Detector?

The FDA 510(k) record lists Ka Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flat Panel Detector?

The FDA product code for Flat Panel Detector is MQB.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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) LimitedK250211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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