# K123508: Trinias

- Pathway: 510(k) (Abbreviated)
- Applicant: Shimadzu Corporation
- Decided: Feb 26, 2014 after 470 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K203535: Trinias (2021), 2 descendants of its own
- K221922: Trinias (2022), 1 descendant of its own
- 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.
- Sep 6, 2024 · Class II · Z-0139-2025: If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is 
- Jan 29, 2024 · Class II · Z-1292-2024: Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.
- Dec 16, 2021 · Class II · Z-0655-2022: Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.
- Nov 18, 2020 · Class II · Z-0555-2021: The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has relea
- Nov 4, 2019 · Class II · Z-2591-2020: The DAP meters were found to be outside of tolerance.
- Jan 14, 2019 · Class II · Z-0864-2019: Two issues: Event 1: Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in 
- Jun 15, 2018 · Class II · Z-0197-2019: Due to a software issue the C-arm may unexpectedly moved when being moved to the park position and during specific operations. There is a possibility the C-arm will come into contact with a patient or

## Indications for use
The Trinias is an Image-intensified fluoroscopic X-ray system, which is used for diagnostic imaging and interventional procedures as described in 21 CFI* 892.1650. 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. The Trinias is intended to be used for interventional procedures such as invasive cardiology, interventional radiology and interventional neuroradiology.

Source page: https://510kreport.com/device/K123508
Methodology: https://510kreport.com/methodology