FDA 510(k)

TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)

K番号: K230136 · 2023-04-24

決定日2023-04-24

製品コードMWP

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-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 K230136. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)?

TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-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 K230136.

When did TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) receive FDA 510(k) clearance?

TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) received FDA 510(k) clearance on 2023-04-24, under 510(k) number K230136.

Who is the listed applicant for TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-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 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)?

The FDA product code for TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) is MWP.

申請者としてCompai Healthcare (Suzhou) Co.,Ltdを記載するその他の記録

K230140TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)

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