Trinias Interventional Fluoroscopic X-Ray System

• • Ongoing Z-2294-2026 FDA Class II ·initiated 20 Apr 2026

  Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.

Full name

Trinias

510(k) Number

K203535 ↗

FDA Product Code

OWB

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Shimasonic Linear/Convex Diagnostic Ultrasound System

  Class II

  FDA 510(k) K973802 Active Cleared 4 Mar 1998

• Shimadzu Whole Body X-Ray CT Scanner Sct-7000TX

  Class II

  FDA 510(k) K955255 Active Cleared 9 Feb 1996

• Shimadzu X-Ray High-Voltage Generator XUD150K

  Class I

  FDA 510(k) K911339 Active Cleared 16 Apr 1991

• Shimadzu X-Ray High-Voltage Generator XUD150B

  Class I

  FDA 510(k) K911280 Active Cleared 17 Jun 1991

• Shimadzu Whole Body X-Ray Computed Tomography Scanner Sct-7000TX W/Fluro Option

  Class II

  FDA 510(k) K984156 Active Cleared 21 Apr 1999

• MU125M Mobile X-Ray System

  Class II

  FDA 510(k) K920393 Active Cleared 6 Apr 1992

See all devices from Shimadzu Medical Systems →

• 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 fluoroscopic visualization during minimally invasive procedures in radiology. It is commonly used to guide interventions such as angiography, cardiology procedures, and orthopedic surgeries, ensuring precise placement of instruments and contrast media.

• Is the Trinias system reusable or single-use, and what does this mean for maintenance and sterility?

  The Trinias is a reusable medical device, meaning it is intended for repeated use in clinical settings. Maintenance and sterility protocols must follow the manufacturer’s guidelines to ensure optimal performance and safety between uses, as it is not designed for single-use.

• How many model variants of the Trinias are registered, and what do these variants typically represent?

  Multiple model variants of the Trinias are registered under the OpenFDA system, each corresponding to specific configurations or accessories. These variants allow for flexibility in clinical settings, accommodating different procedural needs and equipment setups.

• What regulatory pathways has the Trinias undergone, and what does this indicate about its approval status?

  The Trinias has received FDA 510K clearance and complies with the Medical Device Directive (MDD). This indicates that it has been evaluated and deemed substantially equivalent to a legally marketed device in the U.S. and meets the essential requirements of the MDD in Europe.

• Is the Trinias system compatible with MRI environments, and what safety considerations should be taken into account?

  The Trinias is explicitly not classified as MRI-safe or MRI-conditional. This means it should not be used in MRI environments, as its components or operation could interfere with MRI systems or pose risks to patients and staff.