# K250790: Innovision-Dxii

- Pathway: 510(k) (Traditional)
- Applicant: Dk Medical Systems Co., Ltd.
- Decided: Aug 1, 2025 after 140 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: 10 generations back to K981556 (1998). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242119: Innovision-Exii, Dk Medical System (2025) Summary page 5.

## Indications for use
INNOVISION-DXII is a stationery X-ray system intended for obtaining radiographic images of various anatomical parts of the human body, both pediatrics and adults, in a clinical environment. INNOVISION-DXII is not intended for mammography, angiography, interventional, or fluoroscopy use.

Source page: https://510kreport.com/device/K250790
Methodology: https://510kreport.com/methodology