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FDA 510(k)

Kubtec Mozart Supra (XPERT 84) Radiography System

K-Number: K210955 · 2021-09-20

ApplicantKub Technologies, Inc.
Decision Date2021-09-20
Product CodeMWP
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Kubtec Mozart Supra (XPERT 84) Radiography System is a medical device manufactured by Kub Technologies, Inc.. It received FDA 510(k) clearance on 2021-09-20 under approval number K210955. 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 Kubtec Mozart Supra (XPERT 84) Radiography System?

Kubtec Mozart Supra (XPERT 84) Radiography System is a medical device that received FDA 510(k) clearance on 2021-09-20. It is manufactured by Kub Technologies, Inc.. The 510(k) number is K210955.

When was Kubtec Mozart Supra (XPERT 84) Radiography System approved by the FDA?

Kubtec Mozart Supra (XPERT 84) Radiography System received FDA 510(k) clearance on 2021-09-20, under approval number K210955.

What company makes Kubtec Mozart Supra (XPERT 84) Radiography System?

Kubtec Mozart Supra (XPERT 84) Radiography System is manufactured by Kub Technologies, Inc..

What is the FDA product code for Kubtec Mozart Supra (XPERT 84) Radiography System?

The FDA product code for Kubtec Mozart Supra (XPERT 84) Radiography System is MWP.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT06164808 Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch RECRUITING NCT05293197 Safety Study of the Repeated Opening of the Blood-brain Barrier With the SonoCloud® Device to Treat Malignant Brain Tumors in Pediatric Patients RECRUITING NCT03812718 Comparison of Anaesthesia Requirement for Ventilation With Endotracheal Tube Versus Proseal Laryngeal Mask Airway RECRUITING NCT07426809 Margin Optimisation Using Z-axis Assessment With Real-time Tomosynthesis (MOZART Study). RECRUITING

Other Devices by Kub Technologies, Inc.

K183624Kubtec Mozart (Xpert42) K200756Kubtec Mozart Supra K210956Kubtec Mozart (XPERT42) K210957Kubec Xpert 80 Radiography System

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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