Centerline Biomedical, Inc. · Class II · Cleared Feb 17, 2026
| K-number | K254089 |
| Device name | IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) |
| Applicant | Centerline Biomedical, Inc. |
| Product code | DQK |
| Device class | Class II |
| Decision date | Feb 17, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.1425 |
The IOPS Visionary System is a programmable diagnostic computer that displays the position and orientation of sensor-equipped catheters and guidewires in real time using electromagnetic tracking technology. It maps patient vascular anatomy from pre-acquired CT scan data and superimposes navigation overlays to assist clinicians during endovascular interventions in peripheral, aortic, and aortic side branch vasculature as an adjunct to fluoroscopy. The system does not make a diagnosis.
The IOPS Visionary adds several features to the predicate (K243842): support for 50/60 Hz power (versus 60 Hz only), a voltage transformer for European 230V operation, enhanced video splitter capability for dual onboard monitors, live fluoroscopic image overlay functionality, a renamed Interface Module with USB pass-through for tableside control, and a new Tableside Controls Unit (MDC) for bedside operation of software functions. All other core components—System Control Unit, electromagnetic field generator, catheters, guidewires, and fiducial tracking pad—remain functionally identical.
Not stated in this summary.
View the full FDA submission: accessdata.fda.gov