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FDA 510(k)

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

K-Number: K230136 · 2023-04-24

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

Device Summary

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.

Frequently Asked Questions

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.

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.

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

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.

K230140TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)Compai Healthcare (Suzhou) Co.,LtdK213691Solas ORCirdan Imaging, Ltd.K210955Kubtec Mozart Supra (XPERT 84) Radiography SystemKub Technologies, Inc.K210957Kubec Xpert 80 Radiography SystemKub Technologies, Inc.K210956Kubtec Mozart (XPERT42)Kub Technologies, Inc.K202713TrueView 100 ProCompai Healthcare (Shenzhen) Co.,Ltd

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.

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