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FDA 510(k)

一般X光攝影系統(型號:GR10X 40K),一般X光攝影系統(型號:GR10X 50K)

K 號:K220149 · 2022-04-19

決定日期2022-04-19
產品代碼KPR
諮詢委員會RA
決定相當於

器材摘要

General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K) is the device name listed in this FDA 510(k) record. The listed applicant is Xera Medical Systems & Technology , Ltd.. It received FDA 510(k) clearance on 2022-04-19 under 510(k) number K220149. 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 General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)?

General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K) is a medical device that received FDA 510(k) clearance on 2022-04-19. The listed applicant is Xera Medical Systems & Technology , Ltd.. The 510(k) number is K220149.

When did General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K) receive FDA 510(k) clearance?

General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K) received FDA 510(k) clearance on 2022-04-19, under 510(k) number K220149.

Who is the listed applicant for General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)?

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

What is the FDA product code for General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)?

The FDA product code for General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K) is KPR.

相關臨床試驗

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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。

官方來源

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