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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

DateFirm and productCodeLinked 510(k)
Oct 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion S. Model Number: 722285.
Open, Classified
OWBK172822
K181830 +1
Oct 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 7 M20. Model Numbers: 722079, 722224, 722282.
Open, Classified
OWBK172822
K181830 +1
Oct 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 7 M12. Model Numbers: 722078, 722223.
Open, Classified
OWBK172822
K181830 +1
Oct 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 7 B20. Model Numbers: 722068, 722226.
Open, Classified
OWBK172822
K181830 +1
Oct 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 7 B12. Model Numbers: 722067, 722225.
Open, Classified
OWBK172822
K181830 +1
Oct 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 5 M20. Model Numbers: 722228, 722281.
Open, Classified
OWBK172822
K181830 +1
Oct 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 5 M12. Model Number: 722227.
Open, Classified
OWBK172822
K181830 +1
Oct 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 3 M15. Model Number: 722064, 722222, 722280.
Open, Classified
OWBK172822
K181830 +1
Oct 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 3 M12. Model Numbers: 722063, 722221.
Open, Classified
OWBK172822
K181830 +1
Oct 27, 2026Canon Medical System, USA, INC.
ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000V
Open, Classified
OWBK203551
K233107
Oct 27, 2026Canon Medical System, USA, INC.
ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000F
Open, Classified
OWBK182415
Oct 27, 2026Canon Medical System, USA, INC.
ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000C
Open, Classified
OWBK210900
Oct 7, 2026Canon Medical System, USA, INC.
Alphenix INFX-8000C/B5
Open, Classified
OWBK210900
Aug 25, 2026Canon Medical System, USA, INC.
Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for
Open, Classified
OWBK182415
K203551 +1
Aug 10, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system
Open, Classified
OWBK200917
Aug 10, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models ar
Open, Classified
OWBK163715
K172822 +1
Aug 10, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
Open, Classified
OWBK133292
K141979 +2
Aug 5, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.
Open, Classified
OWBK102005
K130638 +4
Aug 5, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221. 2. Azurion 3 M15; Model Numbers: 722064, 722222, 722280.
Open, Classified
OWBK172822
K181830 +1
Aug 5, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbers: 722003, 722010, 722026. 2. Allura Xper FD10 OR Table; Model Number: 7220
Open, Classified
OWBK102005
K130638 +3
Aug 3, 2026Oxos Medical Inc
Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog Number: MC2, MC2.1 Software Version: 5.7.0 Product Description: The MC2 Portable X-Ray System ( MC2 System or MC2
Open, Classified
OWBK252068
Jul 1, 2026Siemens Medical Solutions USA, Inc
ARTIS icono ceiling. Model Number: 11328100.
Open, Classified
OWBK221516
Jul 1, 2026Siemens Medical Solutions USA, Inc
ARTIS icono floor. Model Number: 11327700.
Open, Classified
OWBK241572
Jul 1, 2026Siemens Medical Solutions USA, Inc
ARTIS icono ceiling. Model Number: 11328100.
Open, Classified
OWBK241572
Jul 1, 2026Siemens Medical Solutions USA, Inc
ARTIS icono biplane. Model Number: 11327600.
Open, Classified
OWBK241572
Jun 16, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 722003 for Allura Xper FD10; Model # 722005 for Allura Xper FD
Open, Classified
OWBK102005
K130638 +4
Jun 15, 2026Medtronic Navigation, Inc.-Boxborough
Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Open, Classified
OWBK240465
Jun 5, 2026GE Medical Systems, LLC
Allia Moveo angiographic X-ray system
Open, Classified
OWBK251199
Jun 5, 2026GE Medical Systems, LLC
Allia IGS Pulse angiographic X-ray system
Open, Classified
OWBK232344
Jun 5, 2026GE Medical Systems, LLC
Allia IGS 7 Pulse angiographic X-ray system
Open, Classified
OWBK232344
Jun 5, 2026GE Medical Systems, LLC
Allia IGS 5 Pulse angiographic X-ray system
Open, Classified
OWBK232344
Jun 5, 2026GE Medical Systems, LLC
Allia IGS 3 Pulse angiographic X-ray system
Open, Classified
OWBK232344
Jun 4, 2026Siemens Medical Solutions USA, Inc
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system
Open, Classified
OWBK241572
Jun 4, 2026Siemens Medical Solutions USA, Inc
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Open, Classified
OWBK241572
Jun 2, 2026Shimadzu Medical Systems
Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST alexa:UD150G-40 / D150GC-40; Digital Rad
Open, Classified
OWBK062360
K123508 +4
Jun 1, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Open, Classified
OWBK172822
K181830 +1
Jun 1, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Open, Classified
OWBK172822
K181830 +1
Jun 1, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Open, Classified
OWBK172822
K181830 +1
Jun 1, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Open, Classified
OWBK172822
K181830 +1
Jun 1, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Open, Classified
OWBK172822
K181830 +1
Jun 1, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Open, Classified
OWBK172822
K181830 +1
Jun 1, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Open, Classified
OWBK172822
K181830 +1
Jun 1, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Open, Classified
OWBK172822
K181830 +1
May 28, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper
Open, Classified
OWBK102005
K130638 +4
May 28, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225),
Open, Classified
OWBK102005
K130638 +4
May 21, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 722229
Open, Classified
OWBK172822
K181830 +1
May 21, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integris Allura 15 & 12 (monoplane) (722043), INTEGRIS Allura 15-12 (biplane) (722044
Open, Classified
OWBNone listed
May 21, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027),
Open, Classified
OWBNone listed
May 21, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079,
Open, Classified
OWBNone listed
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

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