FDA 510(k)

Edge Air數位平面X光檢測器

K 號：K172681 · 2017-10-06

決定日期2017-10-06

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

Edge Air Digital Flat Panel X-ray Detector is the device name listed in this FDA 510(k) record. The listed applicant is Osko, Inc.. It received FDA 510(k) clearance on 2017-10-06 under 510(k) number K172681. 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 Edge Air Digital Flat Panel X-ray Detector?

Edge Air Digital Flat Panel X-ray Detector is a medical device that received FDA 510(k) clearance on 2017-10-06. The listed applicant is Osko, Inc.. The 510(k) number is K172681.

When did Edge Air Digital Flat Panel X-ray Detector receive FDA 510(k) clearance?

Edge Air Digital Flat Panel X-ray Detector received FDA 510(k) clearance on 2017-10-06, under 510(k) number K172681.

Who is the listed applicant for Edge Air Digital Flat Panel X-ray Detector?

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

What is the FDA product code for Edge Air Digital Flat Panel X-ray Detector?

The FDA product code for Edge Air Digital Flat Panel X-ray Detector is MQB.

其他以 Osko, 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。

K201503Edge Air(1417)數位平面X光檢測器 K172682邊緣數位平面X光檢測器 K163048智能縫合軟體系統，圖像處理，放射學

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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