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)
Top companies in OWB
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 12, 2021 | Siemens Medical Solutions USA, Inc Artis pheno with software VE20C- diagnostic imaging angiography system
Model: 10849000 Terminated |
OWB | K201156 |
| Sep 24, 2021 | Philips Healthcare Philips Azurion systems with software releases 2.1(L1) and 2.1(L2) Open, Classified |
OWB | K200917 |
| Sep 24, 2021 | Siemens 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 |
OWB | K181407 |
| Sep 22, 2021 | Philips Healthcare ProxiDiagnost N90 is multi-functional general R/F systems. Open, Classified |
OWB | K173433 |
| Aug 13, 2021 | Philips 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 |
OWB | K162148 |
| Aug 13, 2021 | Philips 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 |
OWB | K141979 |
| Aug 13, 2021 | Philips 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 |
OWB | K141979 |
| Jun 30, 2021 | Siemens 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 |
OWB | K181407 |
| Jun 15, 2021 | GE 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 |
OWB | K181403 |
| Jun 10, 2021 | GE 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 |
OWB | K170752 K171565 +2 |
| May 27, 2021 | Siemens Medical Solutions USA, Inc ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures.
Model: 10849000 Open, Classified |
OWB | K163286 K201156 |
| May 26, 2021 | Philips Healthcare Azurion systems with software release R2.0.x Completed |
OWB | K200917 |
| Apr 20, 2021 | Siemens Medical Solutions USA, Inc Multitom RAX with software version VF10 Terminated |
OWB | K152928 |
| Mar 30, 2021 | Siemens 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 |
OWB | K052202 K181407 |
| Mar 26, 2021 | Siemens Medical Solutions USA, Inc Artis zee ceiling-interventional Fluoroscopic X-Ray System
Model Number: 10094137 Open, Classified |
OWB | K181407 |
| Mar 19, 2021 | Siemens 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 |
OWB | K193326 K201156 |
| Feb 26, 2021 | Siemens 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 |
OWB | K193326 |
| Feb 5, 2021 | Canon Medical System, USA, INC. System INFX-8000C Open, Classified |
OWB | K152697 |
| Feb 5, 2021 | Canon Medical System, USA, INC. System INFX-8000V Open, Classified |
OWB | K170909 |
| Jan 28, 2021 | PHILIPS HOME HEALTHCARE SOLUTION ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system Terminated |
OWB | K173433 |
| Dec 18, 2020 | Siemens 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 |
OWB | K193326 |
| Dec 8, 2020 | Canon 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 |
OWB | K152697 |
| Dec 8, 2020 | Canon 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 |
OWB | K170909 |
| Nov 30, 2020 | Siemens Medical Solutions USA, Inc Artis zee/ zeego & Artis Q/ Q.zen
Artis Pheno Open, Classified |
OWB | K181407 |
| Nov 18, 2020 | Shimadzu 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 |
OWB | K123508 |
| Nov 4, 2020 | Siemens 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 |
OWB | K193326 |
| Oct 21, 2020 | Siemens 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 |
OWB | K181407 |
| Oct 8, 2020 | Canon 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 |
OWB | K152697 K181804 |
| Sep 21, 2020 | Siemens 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 |
OWB | K133580 |
| Aug 22, 2020 | Siemens 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 |
OWB | K132094 K181550 +1 |
| Aug 3, 2020 | Siemens 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 |
OWB | K181407 |
| Jul 30, 2020 | Siemens 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 |
OWB | K181550 |
| Jul 30, 2020 | Siemens 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 |
OWB | K181560 |
| Jul 8, 2020 | Canon Medical System, USA, INC. System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147 Open, Classified |
OWB | K181834 |
| May 4, 2020 | Siemens Medical Solutions USA, Inc Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194 Terminated |
OWB | K181550 |
| May 4, 2020 | Siemens 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 |
OWB | K181560 |
| May 4, 2020 | Siemens 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 |
OWB | K181550 |
| May 4, 2020 | Siemens 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 |
OWB | K181560 |
| May 4, 2020 | Siemens 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 |
OWB | K181560 |
| Apr 30, 2020 | Siemens 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 |
OWB | K181407 |
| Apr 29, 2020 | Philips 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 |
OWB | K181830 |
| Apr 23, 2020 | Siemens 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 |
OWB | K193326 |
| Apr 22, 2020 | Siemens 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 |
OWB | K163286 |
| Apr 10, 2020 | Philips 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 |
OWB | K183040 |
| Apr 10, 2020 | Philips 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 |
OWB | K183101 |
| Mar 13, 2020 | Siemens 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 |
OWB | K181407 |
| Mar 13, 2020 | Siemens 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 |
OWB | K181407 |
| Mar 13, 2020 | Siemens 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 |
OWB | K181407 |
| Mar 3, 2020 | Canon 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 |
OWB | K152697 |
| Mar 3, 2020 | Canon 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 |
OWB | K170909 |
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