# K260482: DRE Duo

- Pathway: 510(k) (Traditional)
- Applicant: Jpi Healthcare Co, Ltd.
- Decided: Jun 15, 2026 after 122 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: 8 generations back to K981556 (1998). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192364: GXR-Series Diagnostic X-Ray System, DRGEM Corporation (2019) Summary page 6.

## Indications for use
The DRE Duo is intended for use in hospitals and clinical settings under the supervision of qualified medical professionals. The system is intended to generate X-ray radiation for general radiographic examinations of the human body. The system is designed to be used in conjunction with external image receptors, such as film-based radiography systems or compatible digital detectors, which are not part of the system.

Source page: https://510kreport.com/device/K260482
Methodology: https://510kreport.com/methodology