# K193238: Nexus DR Digital X-Ray Imaging System (with vSharp)

- Pathway: 510(k) (Special)
- Applicant: Varex Imaging Corporation
- Decided: Dec 20, 2019 after 25 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K803130 (1981). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190146: Nexus DR Digital X-ray Imaging System, Varex Imaging Corporation (2019) Summary page 4.

## Indications for use
The Varex Nexus DR Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The Nexus DR Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hard-copy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The major system components include an image receptor, computer, monitor and imaging software. The Varex Nexus DR Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).

Source page: https://510kreport.com/device/K193238
Methodology: https://510kreport.com/methodology