510(k) · Cleared
Recalled · Class II · 2026Trinias
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shimadzu Corporation · OWB Interventional Fluoroscopic X-Ray System
Cleared on Feb 26, 2014 after a 470-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it. It has been recalled 8 times.
- Decided
- Feb 26, 2014
- Review
- 470 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 8
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK123508 TriniasShimadzu Corporation · 2014
- Descendant · cites it directly · 2 of its ownK203535 TriniasShimadzu Corporation Medical Systems · 2021 · Recalled
- Descendant · 2 generations on · 1 of its ownK221922 TriniasShimadzu Corporation Medical Systems Division · 2022 · Recalled
- Descendant · 3 generations on · 0 of its ownK252099 TriniasShimadzu Corporation · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K123508 | Trinias | Shimadzu Corporation | 2014 | — |
| +1 | K203535 | Trinias | Shimadzu Corporation Medical Systems | 2021 | 1 |
| +2 | K221922 | Trinias | Shimadzu Corporation Medical Systems Division | 2022 | 1 |
| +3 | K252099 | Trinias | Shimadzu Corporation | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OWB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203535 | Trinias | 2021 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 20, 2026 | Class II | Z-2294-2026 | Component design/selection | 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 | Software Design Change | 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 released, the table may continue to… |
| Jan 29, 2024 | Class II | Z-1292-2024 | Process change control | 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 | Process change control | 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 | Software design | 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 released the movement lever. This could… |
| Nov 4, 2019 | Class II | Z-2591-2020 | Device Design | The DAP meters were found to be outside of tolerance. |
| Jan 14, 2019 | Class II | Z-0864-2019 | Software design | 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 the morning and makes an error by… |
| Jun 15, 2018 | Class II | Z-0197-2019 | Software design | 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 healthcare personnel. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K203535 (Shimadzu Corporation Medical Systems, 2021) has gone furthest, with 2 descendants of its own.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K123508 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123508: Trinias.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123508
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026