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FDA 510(k)

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

K-Number: K230140 · 2023-04-24

ApplicantCompai Healthcare (Suzhou) Co.,Ltd
Decision Date2023-04-24
Product CodeMWP
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) is a medical device manufactured by Compai Healthcare (Suzhou) Co.,Ltd. It received FDA 510(k) clearance on 2023-04-24 under approval number K230140. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Compai Healthcare (Suzhou) Co.,Ltd. The 510(k) number is K230140.

When was TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) approved by the FDA?

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

What company makes 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 manufactured by Compai Healthcare (Suzhou) Co.,Ltd.

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.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07426809 Margin Optimisation Using Z-axis Assessment With Real-time Tomosynthesis (MOZART Study). RECRUITING

Other Devices by Compai Healthcare (Suzhou) Co.,Ltd

K230136TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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