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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 a medical device manufactured by Kub Technologies, Inc.. It received FDA 510(k) clearance on 2021-08-31 under approval 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. It is manufactured by Kub Technologies, Inc.. The 510(k) number is K210957.

When was Kubec Xpert 80 Radiography System approved by the FDA?

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

What company makes Kubec Xpert 80 Radiography System?

Kubec Xpert 80 Radiography System is manufactured by Kub Technologies, Inc..

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

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

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING

Other Devices by Kub Technologies, Inc.

K183624Kubtec Mozart (Xpert42) K200756Kubtec Mozart Supra K210955Kubtec Mozart Supra (XPERT 84) Radiography System K210956Kubtec Mozart (XPERT42)

Related Devices (Code: MWP)

K153583BioVision PlusFaxitron Bioptics, LLC K170786Faxitron Bioptics Speciemen Radiography SystemFaxitron Bioptics, LLC K173309Faxitron VisionCTFaxitron Bioptics, LLC K192939Volumetric Specimen ImagerClarix Imaging K193317CoreLite X-Ray Specimen CabinetCirdan Imaging Limited K183624Kubtec Mozart (Xpert42)Kub Technologies, Inc.

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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