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., Ziehm Imaging GmbH and Canon Medical Systems Corporation.
FDA 510(k) Cleared Interventional Fluoroscopic X-ray System Devices (Product Code OWB)
About Product Code OWB - Regulatory Context
510(k) Submission Activity
319 total 510(k) submissions under product code OWB since 1991, with 319 receiving FDA clearance (average review time: 112 days).
Submission volume has remained relatively stable over the observed period, with 38 submissions in the last 24 months.
FDA Review Time
Recent submissions under OWB have taken an average of 174 days to reach a decision - up from 103 days historically. Manufacturers should account for longer review timelines in current project planning.
OWB devices are reviewed by the Radiology panel. Browse all Radiology devices →