# K200944: Uniexpert 2 Plus

- Pathway: 510(k) (Traditional)
- Applicant: Adani
- Decided: May 26, 2020 after 48 days
- Product code: KPR (System, X-Ray, Stationary)
- 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: 1 generation back to K011486 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011486: Q-Rad Radiographic System, Quantum Medical Imaging, LLC (2001) Summary page 4.

## Indications for use
The UNIEXPERT 2 PLUS is a stationary general-purpose radiographic imaging system indicated for use in acquiring diagnostic X-Ray images of osseous structures and soft tissues of the human body to aid physicians with patient diagnosis. The system has analogue, computed radiography (CR) as well as digital radiography (DR) imaging capabilities. The UNIEXPERT 2 PLUS is not indicated for use in mammography.

Source page: https://510kreport.com/device/K200944
Methodology: https://510kreport.com/methodology