Guidewires
IOPS Visionary System
by Centerline Biomedical, Inc.
An assembly of devices intended to provide a physician with an electromagnetic (EM) tool for image registration and/or tracking of manual surgical instruments with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., ultrasound (US)] during surgery. It consists of a workstation with controls/display, a line-powered EM field generator, a tracking unit, instruments and trackers with sensors/spatial markers, and adhesive skin markers. It is used for multiple surgical procedures (e.g., ethmoidectomy, tumour resection, fibroid ablation, biopsy, drilling, vascular access) in various fields [e.g., ENT, craniomaxillofacial (CMF), laparoscopic, or orthopaedic surgery].
Where to buy IOPS Visionary System
We do not have contact details for Centerline Biomedical, Inc. yet. Send a request and we will route it to the right person for your country.
IOPS Visionary System models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| MC-3 | — | MR Unsafe | Available |
FDA clearances
- 510(k) K254089 February 2026
Procedures that use guidewires
Frequently asked questions
What is IOPS Visionary System used for?
An assembly of devices intended to provide a physician with an electromagnetic (EM) tool for image registration and/or tracking of manual surgical instruments with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., ultrasound (US)] during surgery. It consists of a workstation with controls/display, a line-powered EM field generator, a tracking unit, instruments and trackers with sensors/spatial markers, and adhesive skin markers. It is used for multiple surgical procedures (e.g., ethmoidectomy, tumour resection, fibroid ablation, biopsy, drilling, vascular access) in various fields [e.g., ENT, craniomaxillofacial (CMF), laparoscopic, or orthopaedic surgery].
Who makes IOPS Visionary System?
IOPS Visionary System is made by Centerline Biomedical, Inc.. It is listed under guidewires in our device library.
What sizes does IOPS Visionary System come in?
The FDA device database does not list sizes for IOPS Visionary System. Check the instructions for use or ask a Centerline Biomedical, Inc. representative.
Is IOPS Visionary System MRI safe?
The FDA device database lists IOPS Visionary System as MR Unsafe. Always follow the specific MRI conditions in the labeling.
Is IOPS Visionary System FDA cleared?
IOPS Visionary System is covered by FDA submission K254089.
How do I contact a Centerline Biomedical, Inc. sales representative?
Centerline Biomedical, Inc. has not listed representatives on LA Vascular yet. Visit the Centerline Biomedical, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.