Kubec Xpert 80 Cabinet X-Ray System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K210957 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 Kubec Xpert 80 Cabinet X-Ray System is a Cabinet, X-Ray System designed for high-resolution radiography. It provides large-field-of-view imaging, enabling detailed visualization of specimens for applications in pathology, biopsy suites, and operating rooms. The system is fully shielded to ensure radiation safety and is configured for versatile use in laboratory settings.
This system is supplied as a reusable medical device, intended for use in radiology environments. It operates under FDA 510(k) clearance (K210957) and MDR authorization, adhering to regulatory standards for Class II devices (892.1680). Multiple configurations accommodate different laboratory requirements, with no specified sterility or MRI compatibility noted. Storage and handling follow standard radiation safety protocols.
Frequently asked questions
What types of environments is the Kubec Xpert 80 Radiography System designed for, and how does its large-field-of-view feature benefit users in those settings?
The Kubec Xpert 80 is specifically designed for high-resolution radiography in pathology labs, biopsy suites, and operating rooms. Its large-field-of-view capability allows for detailed visualization of specimens, making it ideal for capturing comprehensive images of larger samples or complex anatomical structures. This feature enhances diagnostic accuracy by providing clearer, more detailed imaging without the need for multiple exposures or repositioning.
Is the Kubec Xpert 80 Radiography System reusable or single-use, and what does this mean for maintenance and operational workflows?
The Kubec Xpert 80 is a reusable medical device, meaning it is built to withstand repeated use in radiology environments. This design reduces waste and costs associated with single-use alternatives while allowing facilities to maintain a consistent workflow. However, it does require proper cleaning, maintenance, and adherence to radiation safety protocols between uses to ensure reliability and safety.
What safety measures are included in the Kubec Xpert 80 to protect users and patients from radiation exposure?
The Kubec Xpert 80 is fully shielded to minimize radiation exposure, ensuring compliance with safety standards for X-ray systems. Shielding is critical in radiology settings to protect both users and patients from unnecessary radiation. While the system is designed for safety, standard radiation safety protocols—such as limiting exposure time, maintaining proper distance, and using protective gear—should still be followed during operation.
Does the Kubec Xpert 80 come in different configurations, and how might this flexibility benefit a healthcare facility?
Yes, the Kubec Xpert 80 is available in multiple configurations to accommodate varying laboratory requirements. This flexibility allows healthcare facilities to select a setup that best fits their workflow, space constraints, or specific imaging needs. Whether a lab prioritizes portability, integration with existing systems, or specialized imaging capabilities, the adjustable configurations help ensure the system aligns with operational demands.
How should the Kubec Xpert 80 be stored, and are there any special considerations for handling or maintenance?
The Kubec Xpert 80 should be stored in a secure, radiation-safe environment following standard protocols for X-ray systems. This includes keeping it in a designated area away from unauthorized access, ensuring proper ventilation, and protecting it from physical damage. Since it is reusable, regular maintenance—such as calibration, part inspections, and cleaning—is essential to uphold performance, safety, and regulatory compliance over time.
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: XPERT® 80 Cabinet X-ray System - KUBTEC Scientific, XPERT® Specimen Radiography Systems - KUBTEC, The XPERT® 80-L Specimen Radiography System - KUBTEC, XPERT® 80-L X‑ray System - KUBTEC Scientific
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 | K210957 | Class II | Active |
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Manufacturer
- Manufacturer
- Kub Technologies, Inc.
Sources (2)
- FDA 510(k) K210957 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026