OWB

Interventional Fluoroscopic X-Ray System

Product code

OWB

Device name

Interventional Fluoroscopic X-Ray System

Device class

Class 2

21 CFR

21 CFR 892.1650

Medical specialty

Radiology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

57

Summaries archived here

50 (direct download)

510(k) clearances (all years, FDA)

325 (all years; only the last 3 years are listed here)

FDA classification definition

Interventional fluoroscopy

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (57)

Last three years. Most recent: 2026-08-21.

50 summaries are archived here for direct download.