FDA 510(k)

Kubtec 莫扎特超級（XPERT 84）X光攝影系統

K 號：K210955 · 2021-09-20

決定日期2021-09-20

產品代碼MWP

諮詢委員會RA

決定相當於

器材摘要

Kubtec Mozart Supra (XPERT 84) Radiography System is the device name listed in this FDA 510(k) record. The listed applicant is Kub Technologies, Inc.. It received FDA 510(k) clearance on 2021-09-20 under 510(k) number K210955. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Kubtec Mozart Supra (XPERT 84) Radiography System?

Kubtec Mozart Supra (XPERT 84) Radiography System is a medical device that received FDA 510(k) clearance on 2021-09-20. The listed applicant is Kub Technologies, Inc.. The 510(k) number is K210955.

When did Kubtec Mozart Supra (XPERT 84) Radiography System receive FDA 510(k) clearance?

Kubtec Mozart Supra (XPERT 84) Radiography System received FDA 510(k) clearance on 2021-09-20, under 510(k) number K210955.

Who is the listed applicant for Kubtec Mozart Supra (XPERT 84) Radiography System?

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

What is the FDA product code for Kubtec Mozart Supra (XPERT 84) Radiography System?

The FDA product code for Kubtec Mozart Supra (XPERT 84) Radiography System is MWP.

其他以 Kub Technologies, 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。

K210956Kubtec 莫扎特 (XPERT42)K210957Kubec Xpert 80 放射學系統 K200756Kubtec 莫扎特超級 K183624Kubtec 莫扎特 (Xpert42)

相關器械（代碼：MWP）

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。

K230140TrueView Core 100Pro-US 核心標本射線攝影系統（TrueView Core 100Pro-US）Compai Healthcare (Suzhou) Co.,Ltd K230136TrueView 200 Pro-US 藥品檢查射線系統（TrueView 200 Pro-US）Compai Healthcare (Suzhou) Co.,Ltd K213691Solas ORCirdan Imaging, Ltd.K210957Kubec Xpert 80 放射學系統Kub Technologies, Inc.K210956Kubtec 莫扎特 (XPERT42)Kub Technologies, Inc.K202713TrueView 100 ProCompai Healthcare (Shenzhen) Co.,Ltd

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。