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Kubtec Mozart XPERT42

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K210956

by Kub Technologies, Inc.

Identifiers

510(k) Number
K210956 FDA 510(k)
FDA Product Code
MWP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1680 FDA 510(k)
Regulation Number
892.1680 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Kubtec Mozart Xpert42 is a Cabinet, X-Ray System classified as a Class II medical device. It is designed for radiologic imaging, providing diagnostic capabilities within radiology settings to capture high-quality images of internal body structures using X-ray technology.

This system is supplied as a reusable device and is intended for use in clinical radiology departments. It adheres to MRI safety standards as outlined in regulation 892.1680 and is authorized under FDA 510(k) clearance (K210956) and MDR compliance. Multiple registration numbers (3010478247; 3017889703; 3005496266; 3006051164; 3026962577; 3027847687) reflect its regulatory approval for distribution in the United States.

Frequently asked questions

What types of medical settings is the Kubtec Mozart (XPERT42) designed for and how is it used there?

The Kubtec Mozart (XPERT42) is specifically designed for use in clinical radiology departments. It is a reusable Cabinet X-Ray System that provides diagnostic imaging capabilities to capture high-quality X-ray images of internal body structures. Its integration into radiology settings ensures it meets the imaging needs of patients while adhering to MRI safety standards as required by regulation 892.1680.

Is the Kubtec Mozart (XPERT42) a single-use or reusable device, and what does that mean for maintenance?

The Kubtec Mozart (XPERT42) is a reusable device, meaning it is intended to be used multiple times after proper cleaning, disinfection, and maintenance. This design allows for cost-effective operation in radiology departments, though it requires adherence to established protocols for reprocessing to ensure safety, performance, and compliance with regulatory standards.

What regulatory approvals does the Kubtec Mozart (XPERT42) hold, and how does that affect its distribution?

The Kubtec Mozart (XPERT42) holds FDA 510(k) clearance under the reference number K210956, classified as substantially equivalent under the Radiology advisory committee. It also complies with the EU Medical Device Regulation (MDR). The device is distributed in the U.S. under multiple registration numbers (e.g., 3010478247), ensuring it meets the necessary regulatory requirements for distribution and use in clinical settings.

Does the Kubtec Mozart (XPERT42) have any special safety considerations, particularly regarding MRI compatibility?

Yes, the Kubtec Mozart (XPERT42) adheres to MRI safety standards outlined in regulation 892.1680. This means it has been designed and tested to ensure safe use in environments where MRI procedures may be conducted nearby, reducing the risk of interference or hazards associated with magnetic fields.

What does the product code MWP indicate about the Kubtec Mozart (XPERT42) in regulatory filings?

The product code MWP in the regulatory filings for the Kubtec Mozart (XPERT42) categorizes it under the classification system used by the FDA for medical devices. While the exact meaning of MWP isn’t publicly defined in general terms, it is associated with the device’s classification as a Cabinet X-Ray System and its filing under the Radiology advisory committee. This code helps streamline regulatory tracking and submission processes.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Kub Technologies, Inc.

Sources (2)

  • FDA 510(k) K210956 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026