Xpert 40 Specimen Radiography System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K071233 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 Xpert 40 Specimen Radiography System is a Cabinet, X-Ray System designed for high-resolution imaging of biopsy and surgical specimens. It provides real-time radiographic visualization to assist in intraoperative and post-procedure assessment, ensuring accurate specimen evaluation in radiology and biopsy suites.
This system is supplied as a reusable medical device, intended for use in controlled clinical environments such as operating rooms or biopsy suites. It operates under FDA_510K and MDR regulatory frameworks, with a classification of Class II under the Radiology specialty. The system is not MRI-safe and requires proper storage and maintenance as specified by the manufacturer.
Frequently asked questions
What clinical environments is the XPERT 40 Specimen Radiography System designed for use in, and why is this important?
The XPERT 40 is specifically designed for controlled clinical settings like operating rooms and biopsy suites. This is important because it ensures the system operates in environments where sterile conditions and precise imaging are critical for intraoperative and post-procedure specimen assessment, reducing the risk of contamination or misdiagnosis.
Is the XPERT 40 Specimen Radiography System reusable, and what does this mean for maintenance and cost?
Yes, the XPERT 40 is a reusable medical device, which means it is built to withstand repeated use in clinical settings. This design implies that facilities must implement proper cleaning, sterilization, and maintenance protocols as outlined by Kub Technologies to ensure safety and longevity. While reusable systems can reduce upfront costs, they require ongoing investment in maintenance and operational workflows.
Can the XPERT 40 be used in an MRI environment, and if not, what precautions should be taken?
No, the XPERT 40 is explicitly not MRI-safe, meaning it should never be placed in an MRI room or near MRI equipment. Clinicians must ensure the system is stored and operated in areas free from magnetic fields to avoid interference or safety hazards, as the device’s materials or components could be affected by MRI environments.
What types of specimens is the XPERT 40 intended to image, and how does its real-time imaging feature benefit clinicians?
The XPERT 40 is designed for high-resolution imaging of biopsy and surgical specimens, enabling real-time radiographic visualization during or immediately after procedures. This feature allows clinicians to assess specimen integrity, orientation, and completeness on the spot, reducing delays in pathology evaluation and improving intraoperative decision-making.
How do I verify the regulatory compliance of this device before purchasing?
The XPERT 40 holds FDA 510(k) clearance (K071233) and MDR compliance, confirming it meets U.S. and EU regulatory standards for Class II radiology devices. To verify compliance, check the device’s registration numbers (e.g., 3010478247) in the FDA’s OpenFDA database or request manufacturer documentation from Kub Technologies, ensuring the specific model and batch align with approved submissions.
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: The XPERT® 40 Specimen Radiography System | KUBTEC, Efficient, Versatile, Reliable - The XPERT® 40 Specimen Radiography System, PDF The XPERT 40 - mammotome.com, XPERT 40: Specimen radiography system for biopsy inspection, XPERT - Model 40 - Specimen 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 | K071233 | Class II | Active |
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Manufacturer
- Manufacturer
- Kub Technologies, Inc.
Sources (2)
- FDA 510(k) K071233 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026