FDA 510(k)

TrueView Core 100Pro-US 核心标本射线摄影系统（TrueView Core 100Pro-US）

K号: K230140 · 2023-04-24

决定日期2023-04-24

产品代码MWP

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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.

列明Compai Healthcare (Suzhou) Co.,Ltd为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K230136TrueView 200 Pro-US 样本射线摄影系统（TrueView 200 Pro-US）

官方来源

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