Mozart Supra (XPERT 84) Radiography System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K210955 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 Mozart Supra (XPERT 84) Radiography System is a Cabinet, X-Ray System designed for specimen radiography, enabling detailed imaging of excised tissue samples. It incorporates advanced radiography techniques, including 3D Tomosynthesis, to enhance diagnostic accuracy in pathology and surgical settings. This system is classified under Radiology and is intended for use in controlled environments where precise specimen imaging is required.
The system is supplied as a stationary X-ray cabinet and is intended for single-use or reusable components, depending on manufacturer guidelines. It operates under FDA 510(k) clearance (K210955) and MDR compliance, adhering to regulatory standards for Class II medical devices. Storage and handling follow standard radiography protocols, with no specific MRI safety considerations noted. The system is distributed with multiple FEI numbers (3010478247; 3017889703; 3005496266; 3006051164; 3026962577; 3027847687) for regulatory tracking.
Frequently asked questions
What is the primary use of the Kubtec Mozart Supra (XPERT 84) Radiography System in clinical settings?
The Mozart Supra (XPERT 84) Radiography System is specifically designed for specimen radiography, allowing detailed imaging of excised tissue samples. It employs advanced techniques like 3D Tomosynthesis to improve diagnostic accuracy in pathology and surgical environments where precise specimen analysis is critical.
How is the system supplied, and can its components be reused?
The system is supplied as a stationary X-ray cabinet, and its components can be used either single-use or reusable, depending on the manufacturer’s guidelines. This flexibility accommodates different workflow needs in pathology or surgical settings.
Does this device require any special storage or handling considerations beyond standard radiography protocols?
Storage and handling follow standard radiography protocols—no additional MRI safety considerations are noted. However, adherence to general X-ray safety and maintenance guidelines is essential to ensure optimal performance and regulatory compliance.
What regulatory pathways does the Kubtec Mozart Supra (XPERT 84) follow, and how does this affect its use?
The device is cleared under FDA 510(k) (K210955) and complies with MDR (Medical Device Regulation) standards, classifying it as a Class II medical device. This means it meets stringent regulatory requirements for safety and effectiveness before market authorization, ensuring its use aligns with established medical device regulations.
Are there multiple FEI numbers associated with this system, and why?
Yes, the system has six FEI (Facility Establishment Identifier) numbers (e.g., 3010478247, 3017889703) for regulatory tracking. These identifiers help distinguish different registrations or distributions of the device, ensuring proper monitoring and compliance across facilities where it may be used.
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. Sources consulted: MOZART® 3D Specimen Radiography systems - KUBTEC, Kubtec Mozart Supra (XPERT 84) Radiography System (K210955) — FDA 510 ..., KUBTEC | Specimen Radiography Systems & Gamma Probes, Kubtec Mozart Supra (XPERT 84) Radiography System
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K210955 | Class II | Active |
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Manufacturer
- Manufacturer
- Kub Technologies, Inc.
Sources (2)
- FDA 510(k) K210955 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026