FDA 510(k)

Discovery XR656 HD 配合 VolumeRad

K 號：K191699 · 2019-07-24

決定日期2019-07-24

產品代碼KPR

諮詢委員會RA

決定相當於

器材摘要

Discovery XR656 HD with VolumeRad is the device name listed in this FDA 510(k) record. The listed applicant is Ge Hualun Medical Systems Co. , Ltd.. It received FDA 510(k) clearance on 2019-07-24 under 510(k) number K191699. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Discovery XR656 HD with VolumeRad?

Discovery XR656 HD with VolumeRad is a medical device that received FDA 510(k) clearance on 2019-07-24. The listed applicant is Ge Hualun Medical Systems Co. , Ltd.. The 510(k) number is K191699.

When did Discovery XR656 HD with VolumeRad receive FDA 510(k) clearance?

Discovery XR656 HD with VolumeRad received FDA 510(k) clearance on 2019-07-24, under 510(k) number K191699.

Who is the listed applicant for Discovery XR656 HD with VolumeRad?

The FDA 510(k) record lists Ge Hualun Medical Systems Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Discovery XR656 HD with VolumeRad?

The FDA product code for Discovery XR656 HD with VolumeRad is KPR.

其他以 Ge Hualun Medical Systems Co. , Ltd. 為申請人之記錄

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相關器械（代碼：KPR）

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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