FDA 510(k)

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

Número K: K230136 · 2023-04-24

RequerenteCompai Healthcare (Suzhou) Co.,Ltd

Data da decisão2023-04-24

Código do produtoMWP

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam Compai Healthcare (Suzhou) Co.,Ltd como candidato(a)

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

Dispositivos Relacionados (Código: MWP)

K230140TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)Compai Healthcare (Suzhou) Co.,Ltd K213691Solas ORCirdan Imaging, Ltd.K210955Kubtec Mozart Supra (XPERT 84) Radiography SystemKub Technologies, Inc.K210956Kubtec Mozart (XPERT42)Kub Technologies, Inc.K210957Kubec Xpert 80 Radiography SystemKub Technologies, Inc.K202713TrueView 100 ProCompai Healthcare (Shenzhen) Co.,Ltd

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