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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)
110recalls in 12 months (638 all time)
607recalls 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
Mar 26, 2021K202547Surgivisio system
Surgivisio, FR
OWB
Mar 5, 2021K210309Cios Select (VA21) Flat Panel
Siemens Medical Solutions USA, Inc.
OWB
Mar 4, 2021K210307Cios Select (VA21) Image Intensifier
Siemens Medical Solutions USA, Inc.
OWB
Feb 23, 2021K201743ClarifEye R1.0, ClarifEye Needle
Philips Medical Systems Nederlands B.V., NL
OWB
Feb 9, 2021K201583SmartCT R1.0
Philips Medical Systems Nederland B.V., NL
OWB
Feb 5, 2021K210055Cios Alpha
Siemens Medical Solutions USA, Inc.
OWB
Feb 5, 2021K210054Cios Spin
Siemens Medical Systems USA, Inc.
OWB
Dec 23, 2020K202431ControlRad Select Model Z
Controlrad, Inc.
OWB
Dec 22, 2020K203504Cios Flow
Siemens Medical Solutions USA, Inc.
OWB
Dec 22, 2020K203281Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X
Medphoton GmbH, AT
OWB
Dec 18, 2020K203551Alphenix, INFX-8000V/B, /S, V9.1
Canon Medical Systems Corporation, JP
OWB
Sep 16, 2020K202360Ziehm Vision RFD 3D
Ziehm Imaging GmbH, DE
OWB
Jul 13, 2020K200218Digiscan FDX
Allengers Medical Systems Limited, IN
OWB
Jun 29, 2020K201156ARTIS pheno (VE2)
Siemens Medical Solution USA, Inc.
OWB
Jun 24, 2020K200663ControlRad Trace Model 9
Controlrad, Inc.
OWB
May 29, 2020K201172CFP-3131, CFP-2222
Mx Imaging, Inc.
OWB
May 1, 2020K200917Azurion R2.1
Philips Medical Systems Nederland B.V., NL
OWB
Apr 24, 2020K200074O-arm O2 Imaging System
Medtronic, Inc.
OWB
Apr 16, 2020K193326ARTIS Icono
Siemens Medical Solutions USA, Inc.
OWB
Apr 15, 2020K200887AS-10
Canon, Inc., JP
OWB
Apr 3, 2020K200022FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System
Livermoretech, Inc.
OWB
Mar 5, 2020K200360TrackX
Track X Technology, LLC
OWB
Jan 17, 2020K192182C015
Micronica Srl, IT
OWB
Dec 20, 2019K193230Ziehm Vision FD
Ziehm Imaging GmbH, DE
OWB
Dec 19, 2019K183144uMC 560i
Shanghai United Imaging Healthcare Co., Ltd., CN
OWB
Nov 20, 2019K190497Ziehm 8000
Ziehm Imaging GmbH, DE
OWB
Sep 12, 2019K190768ARTIS icono
Siemens Medical Solutions USA, Inc.
OWB
Sep 4, 2019K191503MobileRay Pulse SE Digital Imaging System
Portavision Medical, LLC
OWB
Aug 20, 2019K182086ARCO FP
A.T.S. Applicazione Tecnologie Speciali S.R.L., IT
OWB
Jul 8, 2019K190064nView system 1
Nview Medical, Inc.
OWB
May 13, 2019K183109ControlRad Trace Model 8
Controlrad, Inc.
OWB
Apr 12, 2019K190626SyncVision System
Volcano Corporation
OWB
Dec 31, 2018K183101Zenition 50
Philips Medical Systems Nederland B.V., NL
OWB
Dec 6, 2018K183040Zenition 70
Philips Medical Systems Nederland B.V., NL
OWB
Nov 2, 2018K181403Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR
GE Healthcare, FR
OWB
Oct 30, 2018K181550Cios Spin
Siemens Medical Solutions USA, Inc.
OWB
Oct 24, 2018K181560Cios Alpha
Siemens Medical Systems USA, Inc.
OWB
Oct 17, 2018K182546Alphenix, INFX-8000H/B, V8.0
Canon Medical Systems Corporation, JP
OWB
Sep 28, 2018K182415Alphenix, INFX-8000F/B, V8.0
Canon Medical Systems Corporation, JP
OWB
Sep 10, 2018K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0
Canon Medical Systems Corporation, JP
OWB
Aug 17, 2018K181966SmartPerfusion
Philips Medical Systems Nederlands B.V., NL
OWB
Aug 17, 2018K181943OSCAR (OSCAR Prime, OSCAR Classic)
Genoray Co., Ltd., KR
OWB
Aug 17, 2018K181767Cios Select
Siemens Medical Solutions USA, Inc.
OWB
Aug 15, 2018K181407Artis zee/zeego & Artis Q/Q.zen
Siemens Medical Solution USA, Inc.
OWB
Aug 2, 2018K181830Azurion R2.0
Philips Medical Systems Nederland B.V., NL
OWB
Aug 2, 2018K181804Alphenix, INFX-8000C/B, V8.0
Canon Medical Systems Corporation, JP
OWB
Jul 25, 2018K181670Alphenix, INFX-8000V/B, V8.0
Canon Medical Systems Corporation, JP
OWB
Jul 19, 2018K181834Ultimax-i, DREX-UI80 (V1.60)
Canon Medical Systems Corporation, JP
OWB
Jul 11, 2018K173631Intelli-C
Nrt X-Ray A/S, DK
OWB
Apr 2, 2018K173639Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax
Siemens Medi Cal Solutions, Inc.
OWB

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