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FDA 510(k)

TrueView Core 100Pro-US 核心標本射線攝影系統（TrueView Core 100Pro-US）

K 號：K230140 · 2023-04-24

申請人Compai Healthcare (Suzhou) Co.,Ltd
決定日期2023-04-24
產品代碼MWP
諮詢委員會RA
決定相當於

器材摘要

TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) is the device name listed in this FDA 510(k) record. The listed applicant is Compai Healthcare (Suzhou) Co.,Ltd. It received FDA 510(k) clearance on 2023-04-24 under 510(k) number K230140. 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 TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)?

TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) is a medical device that received FDA 510(k) clearance on 2023-04-24. The listed applicant is Compai Healthcare (Suzhou) Co.,Ltd. The 510(k) number is K230140.

When did TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) receive FDA 510(k) clearance?

TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) received FDA 510(k) clearance on 2023-04-24, under 510(k) number K230140.

Who is the listed applicant for TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)?

The FDA 510(k) record lists Compai Healthcare (Suzhou) Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)?

The FDA product code for TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) is MWP.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Compai Healthcare (Suzhou) Co.,Ltd 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。

K230136TrueView 200 Pro-US 藥品檢查射線系統（TrueView 200 Pro-US）

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。

K230136TrueView 200 Pro-US 藥品檢查射線系統（TrueView 200 Pro-US）Compai Healthcare (Suzhou) Co.,LtdK213691Solas ORCirdan Imaging, Ltd.K210955Kubtec 莫扎特超級（XPERT 84）X光攝影系統Kub Technologies, Inc.K210956Kubtec 莫扎特 (XPERT42)Kub Technologies, Inc.K210957Kubec Xpert 80 放射學系統Kub Technologies, Inc.K202713TrueView 100 ProCompai Healthcare (Shenzhen) Co.,Ltd

官方來源

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