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FDA 510(k)

Qangio XA 3D

K 號：K182611 · 2019-05-30

申請人Medis Medical Imaging Systems BV
決定日期2019-05-30
產品代碼QHA
諮詢委員會RA
決定相當於

器材摘要

Qangio XA 3D is the device name listed in this FDA 510(k) record. The listed applicant is Medis Medical Imaging Systems BV. It received FDA 510(k) clearance on 2019-05-30 under 510(k) number K182611. The device is classified under product code QHA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Qangio XA 3D?

Qangio XA 3D is a medical device that received FDA 510(k) clearance on 2019-05-30. The listed applicant is Medis Medical Imaging Systems BV. The 510(k) number is K182611.

When did Qangio XA 3D receive FDA 510(k) clearance?

Qangio XA 3D received FDA 510(k) clearance on 2019-05-30, under 510(k) number K182611.

Who is the listed applicant for Qangio XA 3D?

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

What is the FDA product code for Qangio XA 3D?

The FDA product code for Qangio XA 3D is QHA.

相關臨床試驗

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相關器械（代碼：QHA）

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。

K251355X1-FFRSpectrawave, Inc.K243769QFR (3.0)Qfr Solutions BVK232147CAAS 工作站Pie Medical Imaging BVK230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.K221711AccuICASArteryFlow Technology Co., Ltd.K210093AccuFFRangioArteryFlow Technology Co., Ltd.

官方來源

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