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Panels › Radiology › Product code OWB · Class 2

Interventional Fluoroscopic X-Ray System

Regulation 892.1650

18510(k)s in 12 months (325 all time)
109recalls in 12 months (637 all time)
606recalls that name a 510(k)
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Top companies in OWB

Company510(k)sRecalls
Siemens Medical Solutions40218
Philips Medical Systems Nederland B.V.29194
Philips Electronics North America Corporation040
Philips North America034
Ziehm Imaging GmbH2112
Canon Medical System, USA, INC.024
GE Medical Systems1110
Ge Oec Medical Systems1011
GE Healthcare515
Philips Medical Systems B.V.812
Decided510(k)Device and applicantCode
Dec 15, 2023K231700Ziehm Vision FD
Ziehm Imaging GmbH, DE
OWB
Dec 15, 2023K230949ARTIS pheno (VE30A)
Siemens Medical Solutions USA, Inc.
OWB
Dec 14, 2023K230950ARTIS icono (VE30A)
Siemens Medical Solutions USA, Inc.
OWB
Dec 12, 2023K231669Ziehm Solo FD
Ziehm Imaging GmbH, DE
OWB
Nov 20, 2023K231692Ziehm Vision RFD
Ziehm Imaging GmbH, DE
OWB
Nov 16, 2023K233200XPLUS 35 Series (XPLUS 35, XPLUS 35FD)
GEMSS HEALTHCARE CO., LTD., KR
OWB
Oct 11, 2023K232344Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR
GE Medical Systems SCS, FR
OWB
Aug 17, 2023K230871EXTRON 5; EXTRON 7
DRTECH Corporation, KR
OWB
Jul 20, 2023K230787Oscar 15 & Oscar 15i
Genoray Co., Ltd., KR
OWB
Jul 10, 2023K231701Ziehm Vision RFD 3D
Ziehm Imaging GmbH, DE
OWB
Jun 20, 2023K222998F3
Acrew Imaging, Inc.
OWB
Jun 1, 2023K230185ANT-X System
Ndr Medical Technology Pte. , Ltd., SG
OWB
Dec 28, 2022K221344nView s1 with nav option
Nview Medical
OWB
Dec 7, 2022K223410Cios Select (VA21) Flat Panel
Siemens Medical Solutions USA, Inc.
OWB
Dec 6, 2022K223409Cios Select (VA21) Image Intensifier
Siemens Medical Solutions USA, Inc.
OWB
Dec 1, 2022K213768Bolt Navigation System
Circinus Medical Technology, LLC
OWB
Nov 17, 2022K221281Multitom Rax
Siemens Medical Solutions
OWB
Oct 25, 2022K222070EndoNaut
Therenva Sas, FR
OWB
Oct 6, 2022K222080Garion Image-Intensified Fluoroscopic X-Ray System, Mobile
Sg Healthcare Co, Ltd., KR
OWB
Sep 30, 2022K222625Shield System
Radiaction , Ltd., IL
OWB
Sep 27, 2022K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3
Canon Medical Systems Corporation, JP
OWB
Jul 28, 2022K221922Trinias
Shimadzu Corporation Medical Systems Division, JP
OWB
Jul 28, 2022K221230TRON
Xoran Technologies, LLC
OWB
Jul 19, 2022K221516ARTIS icono (Ceiling Configuration)
Siemens Medical Solutions USA, Inc.
OWB
Jun 29, 2022K220432ARTIS icono (VE21) System
Siemens Medical Solutions USA, Inc.
OWB
Jun 29, 2022K220409ARTIS pheno (VE21) System
Siemens Medical Solutions USA, Inc.
OWB
Jun 7, 2022K221335D²RS and D²RS 9090
Stephanix, FR
OWB
May 3, 2022K220311Cardiovascular Angiography System
Allengers Medical Systems Limited, IN
OWB
Apr 15, 2022K220946SURGIVISIO Device
Ecential Robotics, FR
OWB
Mar 30, 2022K212159Shield System
Radiaction , Ltd., IL
OWB
Mar 18, 2022K220627SURGIVISIO Device
Ecential Robotics, FR
OWB
Mar 9, 2022K211780ZEN-2090 Turbo
Genoray Co., Ltd., KR
OWB
Feb 18, 2022K212212Multitom Rax with True2scale Body Scan Option
Siemens Medical Solutions
OWB
Dec 23, 2021K213479D²RS and D²RS 9090
Stephanix, FR
OWB
Dec 3, 2021K212442Cydar EV (Series B) and Cydar EV Maps
Cydar , Ltd., GB
OWB
Nov 24, 2021K213455ControlRad Select Model Z
Controlrad, Inc.
OWB
Nov 17, 2021K212336Soteria.AI
Omega Medical Imaging, LLC
OWB
Nov 8, 2021K212956FDR Cross (DR-XD 3000)
Fujifilm Corporation, JP
OWB
Nov 5, 2021K212523VFSS Pro Mobile Digital Imaging System
Imagexray, LLC
OWB
Oct 29, 2021K211064nView s1 with nav option
Nview Medical
OWB
Oct 1, 2021K212813Zenition 70
Philips Medical Systems Nederland B.V., NL
OWB
Sep 24, 2021K212557Virtual C DRF-NEO Digital Imaging System
Portavision Medical, LLC
OWB
Aug 31, 2021K212383EndoNaut
Therenva Sas, FR
OWB
Aug 13, 2021K211777ARCO FP-S
A.T.S. Applicazione Tecnologie Speciali S.R.L., IT
OWB
Aug 12, 2021K210912Excelsius3D
Globus Medical, Inc.
OWB
Jul 1, 2021K211782ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9
Controlrad, Inc.
OWB
Jun 24, 2021K211191Virtual C DRF Digital Imaging System
Portavision Medical, LLC
OWB
Apr 28, 2021K203535Trinias
Shimadzu Corporation Medical Systems, JP
OWB
Apr 12, 2021K210900Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2
Canon Medical Systems Corporation, JP
OWB
Apr 5, 2021K203623StentBoost Mobile
Philips India Limited, IN
OWB

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