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FDA 510(k)

Kubec Xpert 80 Radiography System

K-Number: K210957 · 2021-08-31

ApplicantKub Technologies, Inc.
Decision Date2021-08-31
Product CodeMWP
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Kubec Xpert 80 Radiography System is the device name listed in this FDA 510(k) record. The listed applicant is Kub Technologies, Inc.. It received FDA 510(k) clearance on 2021-08-31 under 510(k) number K210957. 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 Kubec Xpert 80 Radiography System?

Kubec Xpert 80 Radiography System is a medical device that received FDA 510(k) clearance on 2021-08-31. The listed applicant is Kub Technologies, Inc.. The 510(k) number is K210957.

When did Kubec Xpert 80 Radiography System receive FDA 510(k) clearance?

Kubec Xpert 80 Radiography System received FDA 510(k) clearance on 2021-08-31, under 510(k) number K210957.

Who is the listed applicant for Kubec Xpert 80 Radiography System?

The FDA 510(k) record lists Kub Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kubec Xpert 80 Radiography System?

The FDA product code for Kubec Xpert 80 Radiography System is MWP.

Other records listing Kub Technologies, Inc. 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.

K210955Kubtec Mozart Supra (XPERT 84) Radiography SystemK210956Kubtec Mozart (XPERT42)K200756Kubtec Mozart SupraK183624Kubtec Mozart (Xpert42)

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.,LtdK230136TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)Compai Healthcare (Suzhou) Co.,LtdK213691Solas ORCirdan Imaging, Ltd.K210955Kubtec Mozart Supra (XPERT 84) 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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