Nexus DR Digital X-Ray Imaging System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K190146 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 high-resolution digital radiography. It employs a direct radiography (DR) detector to capture and convert X-ray images into digital signals, enabling real-time visualization and diagnostic imaging in radiology settings. The system is optimized for versatile clinical applications, including general radiography, fluoroscopy, and specialized procedures requiring precise imaging.
This imaging system is supplied as a reusable medical device, intended for use in radiology departments and clinical environments. It operates within standard MRI safety guidelines for non-MRI environments and is compatible with multiple detector sizes as referenced in its regulatory filings. The device holds FDA 510(k) clearance and MDR authorization, ensuring compliance with regulatory standards for digital X-ray imaging systems. Storage and handling follow manufacturer guidelines to maintain performance and sterility where applicable.
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.
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 | K190146 | Class II | Active |
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Manufacturer
- Manufacturer
- Varex Imaging Corporation
Sources (2)
- FDA 510(k) K190146 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026