# K251038: Digital Radiographic Imaging Acquisition Software - DR (RiasDR)

- Pathway: 510(k) (Traditional)
- Applicant: Shen Zhen Cambridge-Hit Co., Ltd.
- Decided: Aug 6, 2025 after 125 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K896095 (1990). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152172: Econsole1, DRTECH Corporation (2015) Summary page 5.

## Indications for use
The RiaspDR software directly controls and acquires general radiographic images of human anatomy (excluding fluoroscopic, angiographic, dental and mammographic applications). The RiaspDR software is designed to work with X-ray images from the Mars1417X detector (K210316).

Source page: https://510kreport.com/device/K251038
Methodology: https://510kreport.com/methodology