# K242499: Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Sontu Medical Imaging Equipment Co., Ltd.
- Decided: Jan 6, 2025 after 137 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: 16 generations back to K801623 (1980). 74 ancestors in all.
No later device cites it as a predicate yet.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220919: MULTIX Impact E, Siemens Medical Solutions USA, Inc. (2022) Summary page 6.
- K213700: MULTIX Impact, MULTIX Impact C, Siemens Medical Solutions USA, Inc. (2021) Summary page 6.

## Indications for use
The Digital radiography X-ray system is used in hospitals, clinics, and medical practices. The Digital radiography X-ray system enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. It is not intended for mammographic applications. The Digital radiography X-ray system uses digital detectors for generating diagnostic images by converting X-rays into image signals.

Source page: https://510kreport.com/device/K242499
Methodology: https://510kreport.com/methodology