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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)
Jun 27, 2025Siemens Medical Solutions USA, Inc
interventional fluoroscopic x-ray system
Open, Classified		 OWBK241572
Jun 27, 2025Siemens Medical Solutions USA, Inc
interventional fluoroscopic x-ray system
Open, Classified		 OWBK241572
Jun 27, 2025Siemens Medical Solutions USA, Inc
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Proced
Open, Classified		 OWBK230949
Jun 12, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 72
Open, Classified		 OWBK172822
K181830 +1
Apr 21, 2025Philips Medical Systems Nederland B.V.
Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.
Open, Classified		 OWBK183040
K212813
Apr 21, 2025Philips North America Llc
Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth
Open, Classified		 OWBK142708
Apr 21, 2025Philips North America Llc
Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to
Open, Classified		 OWBK183040
K212813
Apr 21, 2025Philips North America Llc
Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to
Open, Classified		 OWBK183101
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY).
Open, Classified		 OWBK162859
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
Open, Classified		 OWBK033737
K130842 +3
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
Open, Classified		 OWBK033737
K130842 +3
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
Open, Classified		 OWBK033737
K163715 +2
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).
Open, Classified		 OWBK163715
K172822 +1
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).
Open, Classified		 OWBK172822
K200917
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).
Open, Classified		 OWBK200917
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).
Open, Classified		 OWBK033737
K130842 +3
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.
Open, Classified		 OWBK163715
K172822 +1
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10C; Catalog number: 722001
Open, Classified		 OWBK162859
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura CV20; Catalog numbers: 722031
Open, Classified		 OWBK033737
K162859
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/20; Catalog numbers: 722038
Open, Classified		 OWBK033737
K130842 +1
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/15; Catalog numbers: 722058
Open, Classified		 OWBK033737
K130842 +1
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/10; Catalog numbers: 722029
Open, Classified		 OWBK033737
K162859
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.
Open, Classified		 OWBK033737
K130842 +1
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.
Open, Classified		 OWBK130842
K162859
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.
Open, Classified		 OWBK033737
K130842 +1
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
Open, Classified		 OWBK033737
K130842 +2
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.
Open, Classified		 OWBK033737
K130842 +1
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
Open, Classified		 OWBK033737
K130842 +3
Feb 4, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 (3) 722233
Open, Classified		 OWBK172822
K200917
Feb 4, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233
Open, Classified		 OWBK172822
K200917
Feb 4, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236
Open, Classified		 OWBK172822
K200917
Feb 4, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235
Open, Classified		 OWBK200917
Feb 4, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281
Open, Classified		 OWBK200917
Feb 4, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 5 M12 System Code: (1) 722227 (2) 722231
Open, Classified		 OWBK200917
Feb 4, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 3 M15 System Code: (1) 722064 (2) 722222 (3) 722280
Open, Classified		 OWBK200917
Feb 4, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 3 M12 System Code: (1) 722063 (2) 722221
Open, Classified		 OWBK200917
Feb 4, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
AlluraXperFD20/15 System Code: (1) 722058
Open, Classified		 OWBK162859
Feb 4, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/20 System Code: (1) 722038
Open, Classified		 OWBK162859
Feb 4, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
AlluraXperFD20/10 System Code: (1) 722029
Open, Classified		 OWBK162859
Feb 4, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035
Open, Classified		 OWBK162859
Feb 4, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
AlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025
Open, Classified		 OWBK162859
Feb 4, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013
Open, Classified		 OWBK162859
Feb 4, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028
Open, Classified		 OWBK033737
K141979 +1
Feb 4, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10C System Code: (1) 722001
Open, Classified		 OWBK162859
Feb 4, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027
Open, Classified		 OWBK133292
K162859
Feb 4, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026
Open, Classified		 OWBK031333
K041949 +1
Feb 4, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura CV20 System Code: 722031
Open, Classified		 OWBK162859
Jan 29, 2025SIEMENS MEDICAL SOLUTIONS USA, INC
ARTIS One Angiographic X-Ray System
Open, Classified		 OWBK133580
Dec 12, 2024PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 72201
Open, Classified		 OWBK161563
Dec 2, 2024Orthoscan, Inc.
Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system
Open, Classified		 OWBK231701

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