FDA Product Code OWB: Interventional Fluoroscopic X-ray System
Under FDA product code OWB, interventional fluoroscopic X-ray systems are cleared for real-time image guidance during minimally invasive procedures.
These systems provide continuous or pulsed X-ray imaging to guide catheters, wires, and implants during cardiovascular, neurological, and orthopedic interventions. Advanced systems include flat panel detectors, 3D roadmapping, and dose management software.
OWB devices are Class II medical devices, regulated under 21 CFR 892.1650 and reviewed by the FDA Radiology panel.
Leading manufacturers include Siemens Medical Solutions USA, Inc., Canon Medical Systems Corporation and Philips Medical Systems Nederland B.V..
List of Interventional Fluoroscopic X-ray System devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Interventional Fluoroscopic X-ray System devices (product code OWB). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Radiology FDA review panel. Browse all Radiology devices →