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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
DateFirm and productCodeLinked 510(k)
May 12, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 7222
Open, Classified		 OWBK172822
K181830 +1
Apr 16, 2026Siemens Medical Solutions USA, Inc
ARTIS Pheno VE30A and VE40A, Model 10849000
Open, Classified		 OWBK230949
K241572
Apr 7, 2026Siemens Medical Solutions USA, Inc
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
Open, Classified		 OWBK241572
Mar 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
Open, Classified		 OWBNone listed
Mar 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 5 M12; System Code: (1)722227, (2)722231;
Open, Classified		 OWBNone listed
Mar 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
Open, Classified		 OWBNone listed
Mar 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
Open, Classified		 OWBNone listed
Mar 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
Open, Classified		 OWBNone listed
Mar 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;
Open, Classified		 OWBNone listed
Mar 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);
Open, Classified		 OWBNone listed
Mar 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;
Open, Classified		 OWBNone listed
Mar 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/15 OR Table; System Code: 722059;
Open, Classified		 OWBNone listed
Mar 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/15; System Code: 722058;
Open, Classified		 OWBNone listed
Mar 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/20 OR Table; System Code: 722039;
Open, Classified		 OWBNone listed
Mar 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/20; System Code: 722038;
Open, Classified		 OWBNone listed
Mar 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/10; System Code: 722029;
Open, Classified		 OWBNone listed
Mar 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;
Open, Classified		 OWBNone listed
Mar 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;
Open, Classified		 OWBNone listed
Mar 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;
Open, Classified		 OWBNone listed
Mar 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;
Open, Classified		 OWBNone listed
Mar 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
Open, Classified		 OWBNone listed
Mar 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;
Open, Classified		 OWBNone listed
Mar 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
Open, Classified		 OWBNone listed
Mar 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
ALLURA Xper FD10F; System Code: 722002;
Open, Classified		 OWBNone listed
Mar 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10C; System Code: 722001;
Open, Classified		 OWBNone listed
Feb 11, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
Open, Classified		 OWBK172822
K181830 +1
Feb 11, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X
Open, Classified		 OWBK172822
K181830 +1
Feb 11, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
Open, Classified		 OWBK172822
K181830 +1
Feb 11, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X, R3.X
Open, Classified		 OWBK172822
K181830 +1
Feb 11, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.X
Open, Classified		 OWBK172822
K181830 +1
Feb 11, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X
Open, Classified		 OWBK172822
K181830 +1
Feb 11, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
Open, Classified		 OWBK172822
K181830 +1
Feb 11, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X
Open, Classified		 OWBK172822
K181830 +1
Jan 27, 2026Siemens Medical Solutions USA, Inc
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02
Open, Classified		 OWBK250660
Jan 27, 2026Siemens Medical Solutions USA, Inc
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
Open, Classified		 OWBK250660
Jan 27, 2026Canon Medical System, USA, INC.
Alphenix INFX-8000V, interventional fluoroscopic x-ray system
Open, Classified		 OWBK233107
Jan 27, 2026Canon Medical System, USA, INC.
Alphenix INFX-8000H, interventional fluoroscopic x-ray system
Open, Classified		 OWBK182546
Jan 27, 2026Canon Medical System, USA, INC.
Alphenix INFX-8000F, interventional fluoroscopic x-ray system
Open, Classified		 OWBK182415
Jan 27, 2026Canon Medical System, USA, INC.
Alphenix INFX-8000C, interventional fluoroscopic x-ray system
Open, Classified		 OWBK210900
Jan 16, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion system; Software Version Number: R3.1;
Open, Classified		 OWBK200917
Jan 14, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3
Open, Classified		 OWBK172822
K181830 +1
Jan 14, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12.
Open, Classified		 OWBK200917
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/20; Model Number: 722038;
Open, Classified		 OWBK102005
K130638 +4
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/10; Model Number: 722029;
Open, Classified		 OWBK102005
K130638 +4
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20; Model Number: 722028;
Open, Classified		 OWBK102005
K130638 +4
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10/10; Model Number: 722027;
Open, Classified		 OWBK102005
K130638 +4
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10; Model Number: 722026;
Open, Classified		 OWBK102005
K130638 +4
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 OR Table; Model Number: 722023;
Open, Classified		 OWBK102005
K130638 +4
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 Biplane; Model Number: 722013;
Open, Classified		 OWBK102005
K130638 +4
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20; Model Number: 722012;
Open, Classified		 OWBK102005
K130638 +4

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