Interventional Fluoroscopic X-ray System

Product Code: OWB

Radiology Medical Diagnostic X-Ray Equipment

Definition: Interventional Fluoroscopy.

Applicable Standards: Diagnostic X-ray Systems And Their Major Components. [1020.30] Radiographic Equipment. [1020.31] Fluoroscopic Equipment. [1020.32] Computed Tomography (CT) Equipment. [1020.33]

Code of Federal Regulations: 892.1650


Radiation TypeIonizing
Radition SafetyProduct
Annual ReportsYes

Products Classified as OWB

5418Interventional Fluoroscopic X-ray SystemImage-intensified Fluoroscopic X-ray System.

Total Product Life Cycle (TPLC) Devices

5418Interventional Fluoroscopic X-ray SystemImage-intensified Fluoroscopic X-ray System.

FDA Consensus Standards

Interventional Fluoroscopic X-Ray System [37593]21 CFR §892.1650 🔎
Interventional Fluoroscopic X-Ray System [37630]21 CFR §892.1650 🔎
Interventional Fluoroscopic X-Ray System [32778]21 CFR §892.1650 🔎
Interventional Fluoroscopic X-Ray System [33118]21 CFR §892.1650 🔎

Pre-market Notifications for OWB

K213455ControlRad Select Model ZControlRad, Inc.
K212813Zenition 70Philips Medical Systems Nederland BV
K212557Virtual C DRF-NEO Digital Imaging SystemPortavision Medical LLC
K212523VFSS Pro Mobile Digital Imaging SystemIMAGExRAY, LLC
K212336Soteria.AIOmega Medical Imaging, LLC
K211782ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9ControlRad, Inc
K211777ARCO FP-SA.T.S. Applicazione Tecnologie Speciali S.R.L.
K211191Virtual C DRF Digital Imaging SystemPortavision Medical LLC
K211064NView S1 With Nav OptionNView Medical
K210912Excelsius3DGlobus Medical Inc.
K210309Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.
K210307Cios Select (VA21) Image IntensifierSiemens Medical Solutions USA, Inc.
K210055Cios AlphaSiemens Medical Solutions USA, Inc.
K210054Cios SpinSiemens Medical Systems USA, Inc.
K203623StentBoost MobilePhilips India Limited

Global Unique Device Identification Database

00643169869844Interventional fluoroscopic x-ray system
00643169639683Interventional fluoroscopic x-ray system
00763000068097Interventional fluoroscopic x-ray system
00884838086777Interventional Fluoroscopic X-Ray System
00884838085367Interventional Fluoroscopic X-Ray System
00884838085350Interventional Fluoroscopic X-Ray System
00884838085282Interventional Fluoroscopic X-Ray System
00884838085275Interventional Fluoroscopic X-Ray System
00884838085268Interventional Fluoroscopic X-Ray System
00884838085251Interventional Fluoroscopic X-Ray System
00884838084766Interventional Fluoroscopic X-Ray System
00884838083431Interventional Fluoroscopic X-Ray System
00884838080812Interventional Fluoroscopic X-Ray System
00884838080805Interventional Fluoroscopic X-Ray System
00884838080744Interventional Fluoroscopic X-Ray System

Maude Adverse Events

O-ARM O2 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-31
O-ARM SYS O2SANMINA -SCI SYSTEMS2020-03-31
BASE SYS BI70002000 O-ARM SYS O2SANMINA -SCI SYSTEMS2020-03-31
BASE SYS BI70002000 O-ARM SYS O2SANMINA -SCI SYSTEMS2020-03-31
BASE SYS BI70002000 O-ARM SYS O2MEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-31
O-ARM O2 IMAGING SYSTEMSANMINA -SCI SYSTEMS2020-03-30
O-ARM SYS O2MEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-30
2020-03-30
2020-03-30
BASE SYS BI70002000 O-ARM SYS O2MEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-30
BASE SYS BI70002000 O-ARM SYS O2SANMINA -SCI SYSTEMS2020-03-30
O2INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-30
CIOS SPINSIEMENS HEALTHCARE GMBH- AT2020-03-27
ARTIS Q CEILINGSIEMENS HEALTHCARE GMBH- AT2020-03-27
ARTIS ZEE BIPLANESIEMENS HEALTHCARE GMBH- AT2020-03-27
O2INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-26
O2INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEMSANMINA -SCI SYSTEMS2020-03-26
BASE SYS BI70002000 O-ARM SYS O2SANMINA -SCI SYSTEMS2020-03-26
O2INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEMSANMINA -SCI SYSTEMS2020-03-26
BASE SYS BI70002000 O-ARM SYS O2MEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-26
O2INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-25
O-ARMSANMINA -SCI SYSTEMS2020-03-25
O-ARM O2 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-25
BASE SYS BI70002000 O-ARM SYS O2SANMINA -SCI SYSTEMS2020-03-25
BASE SYS BI70002000 O-ARM SYS O2MEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-25
O-ARM SYS O2SANMINA -SCI SYSTEMS2020-03-25
O2INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEMSANMINA -SCI SYSTEMS2020-03-25
BASE SYS BI70002000 O-ARM SYS O2MEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-25
BASE SYS BI70002000 O-ARM SYS O2MEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-25
O-ARM O2 IMAGING SYSTEMSANMINA -SCI SYSTEMS2020-03-24
BASE SYS BI70002000 O-ARM SYS O2MEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-24
O-ARM O2 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-24
O-ARM O2 IMAGING SYSTEMSANMINA -SCI SYSTEMS2020-03-24
BASE SYS BI70002000 O-ARM SYS O2MEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-24
ARTIS ICONO BIPLANESIEMENS HEALTHCARE GMBH- AT2020-03-24
BASE SYS BI70002000 O-ARM SYS O2SANMINA -SCI SYSTEMS2020-03-24
O2 O-ARM IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-23
O-ARM SYS O2MEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-23
O-ARMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-23
O-ARMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-23
O2INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-23
ALLURA XPER FD20PHILIPS HEALTHCARE2020-03-23
OARM O2 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-23
O2INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-23
O2INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-23
ARTIS ZEE FLOORSIEMENS HEALTHCARE GMBH- AT2020-03-23
O-ARM O2 IMAGING SYSTEMSANMINA -SCI SYSTEMS2020-03-23
BASE SYS BI70002000 O-ARM SYS O2MEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-20
O-ARM O2 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-20
BASE SYS BI70002000 O-ARM SYS O2MEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-20

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