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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

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 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.

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. 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.

Other records listing Compai Healthcare (Suzhou) Co.,Ltd as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: MWP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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