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., Philips Medical Systems Nederland B.V. and Ziehm Imaging GmbH.