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Panels › Radiology › Product code OWB · Class 2

Interventional Fluoroscopic X-Ray System

Regulation 892.1650

19510(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
Aug 21, 2026K253726uAngio AVIVA CX
Shanghai United Imaging Healthcare Co., Ltd., CN
OWB
Aug 19, 2026K261413EXTRON 3;EXTRON 6
DRTECH Corporation, KR
OWB
Aug 7, 2026K254205Zenition 30
Philips Medical Systems Nederland B.V., NL
OWB
Jul 31, 2026K260607Shield System (Siemens 30x40)
Radiaction , Ltd., IL
OWB
Jul 10, 2026K253670SmartCT (R3.0 (L10))
Philips Medical Systems B.V., NL
OWB
May 22, 2026K252735C-beam
Pulmera, Inc.
OWB
Apr 30, 2026K252503Intelligent NR
Canon, Inc., JP
OWB
Apr 24, 2026K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno
Siemens Medical Solutions USA, Inc.
OWB
Apr 23, 2026K253752ARTIS genio floor; ARTIS icono.explore floor
Siemens Medical Solutions USA, Inc.
OWB
Apr 2, 2026K252229BELLIGER ACE
Genoray Co., Ltd., CN
OWB
Mar 24, 2026K252099Trinias
Shimadzu Corporation, JP
OWB
Mar 10, 2026K253584Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)
Canon Medical Systems Corporation, JP
OWB
Feb 20, 2026K252500CARA System
Cara Medical, Ltd., VG
OWB
Feb 11, 2026K251992ArmSure Fluoroscopic Positioning System
Savfe Co. , Ltd., TW
OWB
Jan 16, 2026K254186Azurion R3.1
Philips Medical Systems B.V., NL
OWB
Dec 22, 2025K252068MC2 Portable X-ray System
Oxos Medical
OWB
Dec 16, 2025K251893SKAN C PULSAR
Skanray Technologies Limited, IN
OWB
Dec 9, 2025K251199Allia Moveo
GE Medical Systems SCS, FR
OWB
Nov 4, 2025K250241Cios Select
Siemens Medical Solutions USA, Inc.
OWB
Oct 24, 2025K251827Azurion R3.1
Philips Medical Systems B.V., NL
OWB
Oct 10, 2025K251602Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging
Canon Medical Systems Corporation, JP
OWB
Jul 29, 2025K251523Cios Spin
Siemens Medical Solutions USA, Inc.
OWB
Jul 22, 2025K243432Vascular Navigation PAD 2.0; Navigation Software Vascular PAD
Brainlab AG, DE
OWB
Jul 14, 2025K250660LUMINOS Q.namix T; LUMINOS Q.namix R
Siemens Medical Solutions
OWB
Jul 9, 2025K251520Cios Alpha; Cios Flow
Siemens Medical Solutions USA, Inc.
OWB
Jul 7, 2025K243884TAVIPILOT
Caranx Medical, FR
OWB
Jun 10, 2025K250010EXTRON 3; EXTRON 5; EXTRON 7
DRTECH Corporation, KR
OWB
May 19, 2025K243411Diagnostic X-ray System
Nanjing Perlove Medical Equipment Co., Ltd., CN
OWB
May 16, 2025K242731MasteRad MiniX Mobile Digital Imaging System (Mini-X)
Medicatech USA, Inc.
OWB
Apr 30, 2025K250282Persona C HR
A.T.S. Applicazione Tecnologie Speciali S.R.L., IT
OWB
Apr 28, 2025K243376uAngio AVIVA CX
Shanghai United Imaging Healthcare Co., Ltd., CN
OWB
Mar 28, 2025K234067ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)
Medphoton GmbH, AT
OWB
Mar 17, 2025K243646Ziehm Solo FD
Ziehm Imaging GmbH, DE
OWB
Mar 13, 2025K243735Ziehm Vision FD
Ziehm Imaging GmbH, DE
OWB
Feb 25, 2025K2434463DXR
GE Medical Systems SCS, FR
OWB
Jan 21, 2025K243303Ziehm Vision RFD 3D
Ziehm Imaging GmbH, DE
OWB
Jan 15, 2025K243328Ziehm Vision RFD
Ziehm Imaging GmbH, DE
OWB
Dec 6, 2024K241567MC2 Portable X-ray System
Oxos Medical
OWB
Oct 22, 2024K241572ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)
Siemens Medical Solutions USA, Inc.
OWB
Aug 30, 2024K233107Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5
Canon Medical Systems Corporation, JP
OWB
Jun 21, 2024K240465O-arm O2 Imaging System
Medtronic Navigation, Inc.
OWB
Jun 21, 2024K233230See Factor CT3™
Epica International, Inc.
OWB
May 22, 2024K240224Zenition 90
Philips Medical Systems Nederlands B.V., NL
OWB
May 22, 2024K240199IntraOp Alignment System
Alphatec Spine, Inc.
OWB
Apr 26, 2024K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl
Canon, Inc., JP
OWB
Mar 15, 2024K233748CIARTIC Move (VB10)
Siemens Medical Solutions USA, Inc.
OWB
Feb 16, 2024K232420Zenition 30
Philips Medical Systems Nederland B.V., NL
OWB
Feb 5, 2024K240099Ziehm Vision RFD
Ziehm Imaging GmbH, DE
OWB
Jan 30, 2024K240020Ziehm Vision FD
Ziehm Imaging GmbH, DE
OWB
Jan 26, 2024K234109Ziehm Solo FD
Ziehm Imaging GmbH, DE
OWB

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