OWBClass II

Interventional Fluoroscopic X-Ray System

21 CFR 892.1650 / Radiology

OWB is the FDA product code for Interventional Fluoroscopic X-Ray System, a class II device type, regulated under 21 CFR 892.1650. FDA's definition for this code reads: "Interventional fluoroscopy". As of 2026-09-10, FDA records hold 325 510(k) clearances under this code, the most recent dated 2026-08-21, and 624 recalls.

Classification record

Product code: OWB
Device name: Interventional Fluoroscopic X-Ray System
FDA definition: Interventional fluoroscopy
Regulation: 21 CFR 892.1650
Device class: Class II
Review panel: Radiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 325
Ingested recalls: 624

Clearances, product code OWB

By decision year

325 clearances under product code OWB with a decision year between 1991 and 2026, 2021 the highest year at 24.

Show the numbers

510(k) clearances under FDA product code OWB by decision year
Year	Clearances
1991	1
1992	1
1994	2
1996	4
1997	2
1998	4
1999	3
2000	4
2001	5
2002	6
2003	8
2004	9
2005	5
2006	8
2007	3
2008	4
2009	9
2010	7
2011	6
2012	6
2013	11
2014	15
2015	11
2016	16
2017	20
2018	23
2019	9
2020	16
2021	24
2022	21
2023	12
2024	13
2025	22
2026	15

Applicants with the most clearances

Product code OWB

Applicants holding the most 510(k) clearances under product code OWB
Applicant	Clearances
Siemens Medical Solutions USA, Inc.	38
Philips Medical Systems Nederland B.V.	32
GE Healthcare	27
Ziehm Imaging GmbH	21
Philips North America LLC	14
Toshibamedical Systems Corporation	13
Canon Medical Systems Corporation	12
Genoray Co., Ltd.	7
Infimed, Inc.	6
Controlrad, Inc.	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 114 companies shown, in name order