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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

DateFirm and productCodeLinked 510(k)
Oct 12, 2021Siemens Medical Solutions USA, Inc
Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
Terminated
OWBK201156
Sep 24, 2021Philips Healthcare
Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
Open, Classified
OWBK200917
Sep 24, 2021Siemens Medical Solutions USA, Inc
Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061
Open, Classified
OWBK181407
Sep 22, 2021Philips Healthcare
ProxiDiagnost N90 is multi-functional general R/F systems.
Open, Classified
OWBK173433
Aug 13, 2021Philips North America Llc
The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the
Terminated
OWBK162148
Aug 13, 2021Philips North America Llc
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive
Terminated
OWBK141979
Aug 13, 2021Philips North America Llc
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive
Terminated
OWBK141979
Jun 30, 2021Siemens Medical Solutions USA, Inc
Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282
Terminated
OWBK181407
Jun 15, 2021GE Healthcare, LLC
GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840682124638), and Discovery IGS 7 OR (GTIN00840682125
Terminated
OWBK181403
Jun 10, 2021GE OEC Medical Systems, Inc
OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventi
Terminated
OWBK170752
K171565 +2
May 27, 2021Siemens Medical Solutions USA, Inc
ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
Open, Classified
OWBK163286
K201156
May 26, 2021Philips Healthcare
Azurion systems with software release R2.0.x
Completed
OWBK200917
Apr 20, 2021Siemens Medical Solutions USA, Inc
Multitom RAX with software version VF10
Terminated
OWBK152928
Mar 30, 2021Siemens Medical Solutions USA, Inc
Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Mod
Terminated
OWBK052202
K181407
Mar 26, 2021Siemens Medical Solutions USA, Inc
Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137
Open, Classified
OWBK181407
Mar 19, 2021Siemens Medical Solutions USA, Inc
Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and bi
Terminated
OWBK193326
K201156
Feb 26, 2021Siemens Medical Solutions USA, Inc
Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Terminated
OWBK193326
Feb 5, 2021Canon Medical System, USA, INC.
System INFX-8000C
Open, Classified
OWBK152697
Feb 5, 2021Canon Medical System, USA, INC.
System INFX-8000V
Open, Classified
OWBK170909
Jan 28, 2021PHILIPS HOME HEALTHCARE SOLUTION
ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
Terminated
OWBK173433
Dec 18, 2020Siemens Medical Solutions USA, Inc
ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedur
Terminated
OWBK193326
Dec 8, 2020Canon Medical System, USA, INC.
Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and ang
Open, Classified
OWBK152697
Dec 8, 2020Canon Medical System, USA, INC.
Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and an
Open, Classified
OWBK170909
Nov 30, 2020Siemens Medical Solutions USA, Inc
Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
Open, Classified
OWBK181407
Nov 18, 2020Shimadzu Medical Systems
Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography,
Open, Classified
OWBK123508
Nov 4, 2020Siemens Medical Solutions USA, Inc
ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and intervent
Terminated
OWBK193326
Oct 21, 2020Siemens Medical Solutions USA, Inc
Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 10848281, 10848354, 10094135, 10848354 - Product Usage: Artis is a family of dedica
Terminated
OWBK181407
Oct 8, 2020Canon Medical System, USA, INC.
CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers: Infinix-8000C and Infinix-8000H - Product Usage: This device is a digital radiogr
Terminated
OWBK152697
K181804
Sep 21, 2020Siemens Medical Solutions USA, Inc
Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he examination table as an integrated part of the system can be used for X-ray ima
Terminated
OWBK133580
Aug 22, 2020Siemens Medical Solutions USA, Inc
Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the
Terminated
OWBK132094
K181550 +1
Aug 3, 2020Siemens Medical Solutions USA, Inc
Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE 10848282 ARTIS Q CEI
Terminated
OWBK181407
Jul 30, 2020Siemens Medical Solutions USA, Inc
Cios Spin, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical
Terminated
OWBK181550
Jul 30, 2020Siemens Medical Solutions USA, Inc
Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinica
Terminated
OWBK181560
Jul 8, 2020Canon Medical System, USA, INC.
System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
Open, Classified
OWBK181834
May 4, 2020Siemens Medical Solutions USA, Inc
Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194
Terminated
OWBK181550
May 4, 2020Siemens Medical Solutions USA, Inc
Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA30-10308194 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the a
Terminated
OWBK181560
May 4, 2020Siemens Medical Solutions USA, Inc
Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 - Product Usage: The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures
Terminated
OWBK181550
May 4, 2020Siemens Medical Solutions USA, Inc
Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient durin
Terminated
OWBK181560
May 4, 2020Siemens Medical Solutions USA, Inc
Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during
Terminated
OWBK181560
Apr 30, 2020Siemens Medical Solutions USA, Inc
Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q floor Model: 10848280; Artis Q ceiling Model: 10848281; Artis Q biplane Model:1084
Terminated
OWBK181407
Apr 29, 2020Philips North America, LLC
Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluoroscopic x-ray system System code: 722079
Terminated
OWBK181830
Apr 23, 2020Siemens Medical Solutions USA, Inc
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
Terminated
OWBK193326
Apr 22, 2020Siemens Medical Solutions USA, Inc
ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Product Usage: is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventio
Terminated
OWBK163286
Apr 10, 2020Philips North America, LLC
Philips Zenition 70, System code 718133 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, exc
Terminated
OWBK183040
Apr 10, 2020Philips North America, LLC
Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, exc
Terminated
OWBK183101
Mar 13, 2020Siemens Medical Solutions USA, Inc
Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 Product Usage: Artis is a family of dedicated angiogr
Terminated
OWBK181407
Mar 13, 2020Siemens Medical Solutions USA, Inc
Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: Artis is a family of dedicated angiography systems developed for si
Terminated
OWBK181407
Mar 13, 2020Siemens Medical Solutions USA, Inc
Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: Artis is a family of dedicated angiography
Terminated
OWBK181407
Mar 3, 2020Canon Medical System, USA, INC.
Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration
Open, Classified
OWBK152697
Mar 3, 2020Canon Medical System, USA, INC.
Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration
Open, Classified
OWBK170909

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