Trinias Interventional Fluoroscopic X-Ray System
by Shimadzu Corporation Medical Systems Division
510(k) K221922
Active
Valid until
Not listed
FDA recalls
1 ongoingTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK221922 | Date28 Jul 2022 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Recalls
-
- Ongoing 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.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Full name
- Trinias
- 510(k) Number
- FDA Product Code
- OWB
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1650
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Trinias is an Interventional Fluoroscopic X-Ray System, designed for real-time imaging during minimally invasive procedures. It provides high-resolution fluoroscopy to guide interventions such as angiography, cardiac catheterization, and orthopedic surgeries, ensuring precise visualization of internal structures in real time.
This system is supplied as a reusable medical device, intended for use in radiology departments and operating rooms. It is not classified as MRI-safe or MRI-conditional, and its regulatory authorizations include FDA 510K clearance and MDD compliance. Multiple model references are listed, indicating variations in configuration or software versions, though no specific sterility or single-use designation is noted.
Other devices from Shimadzu Corporation Medical Systems Division
Questions
AI-generated answers, 18 Sep 2026
What types of medical procedures is the Trinias designed to assist with using its real-time imaging capabilities?
The Trinias is specifically designed for real-time imaging during minimally invasive procedures such as angiography, cardiac catheterization, and orthopedic surgeries. Its high-resolution fluoroscopy provides precise visualization of internal structures, making it ideal for guiding interventions where accurate imaging is critical.
Is the Trinias system intended for single-use or can it be reused in clinical settings?
The Trinias is supplied as a reusable medical device, meaning it is intended for repeated use in radiology departments and operating rooms. It is not designated as single-use, so proper cleaning, maintenance, and sterilization protocols must be followed between procedures.
What regulatory pathways has the Trinias undergone, and which governing bodies have authorized its use?
The Trinias has received FDA 510K clearance and complies with the Medical Device Directive (MDD). These authorizations confirm its substantial equivalence to a predicate device and adherence to European regulatory standards, ensuring its use is authorized in both the U.S. and EU markets.
Are there different model variations of the Trinias, and if so, what do these variations typically represent?
Yes, the Trinias includes multiple model references, which likely correspond to variations in configuration, software versions, or technical specifications. These differences may cater to different clinical needs or operational setups, such as adjustments for room size, imaging requirements, or integration with other systems.
Can the Trinias be used in an MRI environment, or does it pose any risks in such settings?
The Trinias is explicitly not classified as MRI-safe or MRI-conditional. This means it should not be used in an MRI environment, as it may interfere with MRI equipment or pose risks to patients and staff during MRI procedures.