ClearanceBrief
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)
Get daily alerts for OWBSample briefCSV

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)
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10/10; Model Number: 722011;
Open, Classified		 OWBK102005
K130638 +4
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10; Model Number: 722010;
Open, Classified		 OWBK102005
K130638 +4
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 Biplane; Model Number: 722008;
Open, Classified		 OWBK102005
K130638 +4
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20; Model Number: 722006;
Open, Classified		 OWBK102005
K130638 +4
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10/10; Model Number: 722005;
Open, Classified		 OWBK102005
K130638 +4
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10; Model Number: 722003;
Open, Classified		 OWBK102005
K130638 +4
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10F; Model Number: 722002;
Open, Classified		 OWBK102005
K130638 +4
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Product Name: Allura Xper FD10C; Model number: 722001;
Open, Classified		 OWBK102005
K130638 +4
Jan 8, 2026Siemens Medical Solutions USA, Inc
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Open, Classified		 OWBK173639
Nov 26, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
Open, Classified		 OWBK200917
Oct 23, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Open, Classified		 OWBK183101
Oct 8, 2025Canon Medical System, USA, INC.
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for
Open, Classified		 OWBK210900
K233107
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified		 OWBK041949
K130842
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified		 OWBK041949
K130842
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified		 OWBK041949
K130842
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified		 OWBK041949
K130842
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified		 OWBK041949
K130842
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified		 OWBK041949
K130842
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified		 OWBK041949
K130842
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified		 OWBK041949
K130842
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified		 OWBK041949
K130842
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified		 OWBK041949
K130842
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified		 OWBK041949
K130842
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified		 OWBK041949
K130842
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified		 OWBK041949
K130842
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified		 OWBK041949
K130842
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified		 OWBK041949
K130842
Sep 25, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Open, Classified		 OWBK102005
K130638 +4
Sep 25, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Open, Classified		 OWBK102005
K130638 +4
Sep 25, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Open, Classified		 OWBK102005
K130638 +4
Sep 25, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Open, Classified		 OWBK102005
K130638 +4
Sep 25, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Open, Classified		 OWBK102005
K130638 +4
Sep 25, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Open, Classified		 OWBK102005
K130638 +4
Sep 25, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Open, Classified		 OWBK102005
K130638 +4
Sep 25, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Open, Classified		 OWBK102005
K130638 +4
Sep 25, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Open, Classified		 OWBK102005
K130638 +4
Sep 25, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Open, Classified		 OWBK102005
K130638 +4
Sep 25, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Open, Classified		 OWBK102005
K130638 +4
Sep 25, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Open, Classified		 OWBK102005
K130638 +4
Sep 25, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Open, Classified		 OWBK102005
K130638 +4
Sep 5, 2025Siemens Medical Solutions USA, Inc
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Open, Classified		 OWBK241572
Sep 3, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003. 2. Allura Xper FD10/10, M
Open, Classified		 OWBK102005
K130638 +3
Sep 3, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper
Open, Classified		 OWBK102005
K130842 +3
Sep 3, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M1
Open, Classified		 OWBK172822
K181830 +1
Aug 22, 2025GE Medical Systems, LLC
GE HealthCare OEC 9900 Elite C-arm Systems.
Open, Classified		 OWBK073543
K082781 +2
Aug 22, 2025GE Medical Systems, LLC
GE HealthCare OEC 9800.
Open, Classified		 OWBK021049
K111551 +1
Jul 29, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allu
Open, Classified		 OWBK133292
K141979 +2
Jul 18, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M20. Fluoroscopic X-Ray System.
Open, Classified		 OWBK163715
K172822 +1
Jul 9, 2025Medtronic Navigation, Inc.-Boxborough
O-arm O2 Imaging System. Mobile X-Ray System.
Open, Classified		 OWBK240465
Jun 27, 2025Siemens Medical Solutions USA, Inc
interventional fluoroscopic x-ray system
Open, Classified		 OWBK241572

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.