# K252099: Trinias

- Pathway: 510(k) (Abbreviated)
- Applicant: Shimadzu Corporation
- Decided: Mar 24, 2026 after 264 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K123508 (2014). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221922: Trinias, Shimadzu Corporation Medical Systems Division (2022) Summary page 5.

## Indications for use
The Trinias is an angiographic X-ray system which is used for diagnostic imaging and interventional procedures. The Trinias is intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.

Source page: https://510kreport.com/device/K252099
Methodology: https://510kreport.com/methodology