# K221922: Trinias

- Pathway: 510(k) (Special)
- Applicant: Shimadzu Corporation Medical Systems Division
- Decided: Jul 28, 2022 after 27 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K123508 (2014). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203535: Trinias, Shimadzu Corporation Medical Systems (2021) Summary page 4.

## Most influential descendants
- K252099: Trinias (2026), 0 descendants of its own

## Recalls of this device
- Apr 20, 2026 · Class II · Z-2294-2026: Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.

## 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/K221922
Methodology: https://510kreport.com/methodology