# K242119: Innovision-Exii

- Pathway: 510(k) (Traditional)
- Applicant: Dk Medical System
- Decided: Jan 3, 2025 after 168 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: 9 generations back to K981556 (1998). 15 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202572: GXR-Series Diagnostic X-Ray System, DRGEM Corporation (2020) Summary page 5.

## Most influential descendants
- K253446: AeroDR TX c02 (2026), 0 descendants of its own
- K250790: Innovision-Dxii (2025), 0 descendants of its own

## Indications for use
INNOVISION-EXII 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-EXII is not intended for mammography, angiography, interventional, or fluoroscopy use.

Source page: https://510kreport.com/device/K242119
Methodology: https://510kreport.com/methodology