Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K172951 FDA 510(k)
- FDA Product Code
- MQB 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 Nexus DR Digital X-ray Imaging System is a Solid State X-Ray Imager (Flat Panel/Digital Imager) designed for digital radiography. It replaces conventional film-based systems by capturing X-ray radiation via integrated PaxScan 4343RC or PaxScan 4343Rv3 flat panel detectors, enabling high-resolution digital image acquisition for diagnostic imaging in radiology settings.
This system is intended for use in radiology departments, where it is supplied as a Class II medical device with FDA 510(k) clearance under Special Review (K172951). The detectors are reusable components, and the system operates in non-sterile environments. Compatibility with MRI environments is not specified. Multiple detector sizes are available, as indicated by the listed FEI numbers, and the device requires proper storage to maintain performance. Authorisation details include regulatory classification under 892.1680 and submission to the Radiology Advisory Committee.
Frequently asked questions
What is the Nexus DR Digital X-ray Imaging System used for?
The Nexus DR Digital X-ray Imaging System is designed for digital radiography, replacing traditional film-based systems. It captures X-ray radiation using integrated PaxScan 4343RC or PaxScan 4343Rv3 flat panel detectors to produce high-resolution digital images. This system is intended for use in radiology departments to improve diagnostic imaging efficiency and accuracy.
How is the Nexus DR Digital X-ray Imaging System supplied, and is it reusable?
The system is supplied as a Class II medical device with FDA 510(k) clearance. The PaxScan 4343RC and PaxScan 4343Rv3 flat panel detectors are reusable components, allowing for long-term use in clinical settings. This design helps reduce waste and operational costs compared to single-use systems.
Are the detectors for the Nexus DR system sterile, and where should they be stored?
The detectors are not sterile and are intended for use in non-sterile environments. Proper storage is essential to maintain their performance and longevity. Follow manufacturer guidelines for storage conditions, such as protecting the detectors from physical damage, extreme temperatures, and contamination.
What sizes or models of detectors are available for the Nexus DR system?
The Nexus DR system supports multiple detector sizes, each identified by a unique FEI (Final Equipment Identification) number. These include models like 3009717300, 3015223550, 3014544225, and others listed under the product specifications. The specific FEI number determines the detector’s dimensions and compatibility with the system.
What regulatory pathway was followed for the Nexus DR Digital X-ray Imaging System?
The Nexus DR Digital X-ray Imaging System was submitted to the FDA under the 510(k) clearance process, specifically as a Special Review (K172951). It was classified under product code MQB and regulatory category 892.1680. The submission was reviewed by the Radiology Advisory Committee (RA) and determined to be substantially equivalent to a predicate device.
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: Nexus Mods - Mods and Community, Nexus DR™Digital Imaging System | Varex Imaging, Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan ..., Varex Nexus DR Digital X-Ray Imaging (with PaxScan 4343RC…, PDF NEXUS DR - Varex Imaging
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172951 | Class II | Active |
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Manufacturer
- Manufacturer
- Varex Imaging Corporation
Sources (1)
- FDA 510(k) K172951 24 fields · synced Oct 1, 2026