← Back to catalogue

Kubtec X250

FDA 510(k)

Class II (US FDA 510(k))

510(k) K141539

by Kub Technologies, Inc.

Identifiers

510(k) Number
K141539 FDA 510(k)
FDA Product Code
IZL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1720 FDA 510(k)
Regulation Number
892.1720 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Kubtec X250 is a mobile X-ray system designed for radiologic imaging. It is classified as a mobile X-ray system under the nomenclature for radiographic imaging equipment, providing portable radiographic capabilities for clinical use.

This device is intended for single-use or reusable applications in radiology settings, depending on facility protocols. It is regulated under 21 CFR 892.1720 and holds FDA 510(k) clearance (K141539) for use as a Class II medical device. The Kubtec X250 is supplied with various FEI numbers and registration identifiers, ensuring compliance with regulatory requirements.

Frequently asked questions

Can the Kubtec X250 be used in both single-use and reusable settings, and how should facilities determine the appropriate use case?

The Kubtec X250 is designed for use in both single-use and reusable applications, depending on facility protocols. Whether to use it as a single-use or reusable device should be determined by the facility’s infection control policies, maintenance capabilities, and regulatory compliance requirements. The device’s flexibility allows it to adapt to these varying operational needs.

What regulatory pathway was followed for the FDA clearance of the Kubtec X250, and what does this mean for its compliance?

The Kubtec X250 received FDA clearance through a 510(k) submission (K141539) under the Traditional Review pathway, classified as Substantially Equivalent (SE) to a predicate device. This means it meets FDA standards for safety and effectiveness as a Class II medical device under 21 CFR 892.1720, ensuring compliance with U.S. regulatory requirements for mobile X-ray systems.

How many unique FEI numbers are associated with the Kubtec X250, and what purpose do they serve?

The Kubtec X250 is linked to 40+ unique FEI (Facility Equipment Identifier) numbers, such as 3015223550, 3002808139, and others listed in the data. These identifiers are used for tracking, inventory management, and regulatory reporting by healthcare facilities, ensuring traceability and compliance with U.S. medical device registration requirements.

Is the Kubtec X250 intended for use in specific clinical specialties, and how does this affect its versatility?

The Kubtec X250 is primarily designated for radiology settings, as indicated by its classification under the Radiology medical specialty. While it is not limited to a single procedure or specialty, its design aligns with portable radiographic imaging needs, making it suitable for general radiology use across hospitals, clinics, and mobile imaging units.

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: KUBTEC | Specimen Radiography Systems & Gamma Probes, KUBTEC X250 (K141539) — FDA 510 (k) | Innolitics, Kub Kubtec X250 - allmed.wiki

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Kub Technologies, Inc.

Sources (1)

  • FDA 510(k) K141539 24 fields · synced Sep 19, 2026