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) |
|---|---|---|---|
| Jun 6, 2019 | Siemens Medical Solutions USA, Inc Siemens Artis Q zeego ---Interventional Fluoroscopic X-Ray System
Model Number: 10848283 Terminated |
OWB | K181407 |
| Jun 6, 2019 | Siemens Medical Solutions USA, Inc Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System
Model Number: 10848282 Terminated |
OWB | K181407 |
| Jun 6, 2019 | Siemens Medical Solutions USA, Inc Siemens Artis Q ceiling--Interventional Fluoroscopic X-Ray System
Model Number: 10848281 Terminated |
OWB | K181407 |
| Jun 6, 2019 | Siemens Medical Solutions USA, Inc Siemens Artis Q floor --Interventional Fluoroscopic X-Ray System
Model Number: 10848280 Terminated |
OWB | K181407 |
| Jun 6, 2019 | Siemens Medical Solutions USA, Inc Siemens Artis zeego--Interventional Fluoroscopic X-Ray System
Model Number: 10280959 Terminated |
OWB | K181407 |
| Jun 6, 2019 | Siemens Medical Solutions USA, Inc Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System
Model Number: 10094141 Terminated |
OWB | K181407 |
| Jun 6, 2019 | Siemens Medical Solutions USA, Inc Siemens Artis zee ceiling -Interventional Fluoroscopic X-Ray System
Model Number: 10094137 Terminated |
OWB | K181407 |
| Jun 6, 2019 | Siemens Medical Solutions USA, Inc Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System
Model Number: 10094135 Terminated |
OWB | K181407 |
| Mar 22, 2019 | Siemens Medical Solutions USA, Inc Cios Alpha with software version VA30-mobile C-arm x-ray
Material # 11105200
Product Usage:
The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of p Terminated |
OWB | K181560 |
| Mar 18, 2019 | Siemens Medical Solutions USA, Inc Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinica Terminated |
OWB | K132094 |
| Feb 28, 2019 | Philips North America, LLC URODiagnost Eleva, Product codes 708026, 708027, 708028
Product Usage:
The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide ran Terminated |
OWB | K032046 |
| Feb 8, 2019 | Siemens Medical Solutions USA, Inc Uroskop Omnia Max -fluoroscopic X-ray system
Model # 10762473
Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. Terminated |
OWB | K173639 |
| Jan 14, 2019 | Shimadzu Medical Systems Usa Com TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose ang Terminated |
OWB | K123508 |
| Nov 30, 2018 | Philips Medical Systems Nederlands Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2 Terminated |
OWB | K172822 |
| Nov 2, 2018 | Stephanix STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png
Product The D2RS Digital Dynamic Remote System is indicated for use in generating fluoroscopic images Terminated |
OWB | K102529 |
| Oct 19, 2018 | Siemens Medical Solutions USA, Inc ARTIS Q.zen biplane with Material 10848355
- a Angiographic x-ray system
Product Usage:
Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventio Terminated |
OWB | K123529 |
| Oct 19, 2018 | Siemens Medical Solutions USA, Inc ARTIS Q biplane with Material 10848282-
- a Angiographic x-ray system
Product Usage:
Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional Terminated |
OWB | K123529 |
| Oct 19, 2018 | Shimadzu Medical Systems Usa Com TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiogr Terminated |
OWB | K123508 |
| Oct 5, 2018 | GE Medical Systems, SCS Discovery IGS 740 Interventional Fluoroscopic X-ray Systems Terminated |
OWB | K133278 |
| Oct 5, 2018 | GE Medical Systems, SCS Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems Terminated |
OWB | K111209 K122457 |
| Oct 5, 2018 | GE Medical Systems, SCS Discovery IGS 730 Interventional Fluoroscopic X-ray Systems Terminated |
OWB | K113403 K122457 |
| Sep 21, 2018 | Philips Electronics North America Corporation Allura Xper F020 Biplane DR Table, System Code 722020
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
OWB | K141979 |
| Sep 21, 2018 | Philips Electronics North America Corporation Allura Xper F010/10 DRTable, System Code 722019
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
OWB | K141979 |
| Sep 21, 2018 | Philips Electronics North America Corporation Allura Xper F020 DR Table, System Code 722015
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
OWB | K141979 |
| Sep 21, 2018 | Philips Electronics North America Corporation Allura Xper F010 DR Table, System Code 722014
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
OWB | K141979 |
| Sep 21, 2018 | Philips Electronics North America Corporation Allura Xper F020 DR Table, System Code 722023
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
OWB | K141979 |
| Sep 21, 2018 | Philips Electronics North America Corporation AIIura Xper F010 DR Table, System Code 722022
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
OWB | K141979 |
| Sep 17, 2018 | Medtronic Navigation, Inc.-Littleton Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system:
OARM BI70002000 SYS IMAGING 02
Model: BI70002000
OARM BI70002000R SYS IMAGING 02 REFURB
Model: BI70002000R Terminated |
OWB | K173664 |
| Jul 29, 2018 | Siemens Medical Solutions USA, Inc ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000 Terminated |
OWB | K163286 |
| Jul 29, 2018 | Siemens Medical Solutions USA, Inc Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355 Terminated |
OWB | K123529 |
| Jun 27, 2018 | Philips Medical Systems Nederlands OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025 Terminated |
OWB | K982993 |
| Jun 22, 2018 | Siemens Medical Solutions USA, Inc ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System
Product Usage:
Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interven Terminated |
OWB | K163286 |
| Jun 22, 2018 | Siemens Medical Solutions USA, Inc Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355
Product Usage:
Artis is a family of dedicated angiography systems developed for single and b Terminated |
OWB | K123529 |
| Jun 11, 2018 | Philips Healthcare Centron
Product Usage:
Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications includin Terminated |
OWB | None listed |
| Jun 11, 2018 | Philips Healthcare UNIQ
Product Usage:
Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including d Terminated |
OWB | None listed |
| Jun 11, 2018 | Philips Healthcare Allura Xper
Product Usage:
Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications incl Terminated |
OWB | None listed |
| May 30, 2018 | Siemens Medical Solutions USA, Inc ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000 Terminated |
OWB | K163286 |
| May 25, 2018 | Siemens Medical Solutions USA, Inc Artis zee systems with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures. Terminated |
OWB | K141574 |
| May 1, 2018 | Siemens Medical Solutions USA, Inc Artis zeego, Material no. 10280959
, for angiography and whole body radiographic/fluoroscopic procedures. Terminated |
OWB | K141574 |
| May 1, 2018 | Siemens Medical Solutions USA, Inc Artis zee MP, Material no. 10094139, for angiography and whole body radiographic/fluoroscopic procedures. Terminated |
OWB | K141574 |
| May 1, 2018 | Siemens Medical Solutions USA, Inc Artis zee floor MN, Material no. 10094142, for angiography and whole body radiographic/fluoroscopic procedures. Terminated |
OWB | K141574 |
| May 1, 2018 | Siemens Medical Solutions USA, Inc Artis zee floor, Material no. 10094135, for angiography and whole body radiographic/fluoroscopic procedures. Terminated |
OWB | K141574 |
| May 1, 2018 | Siemens Medical Solutions USA, Inc Artis zee ceiling, Material no. 10094137, for angiography and whole body radiographic/fluoroscopic procedures. Terminated |
OWB | K141574 |
| May 1, 2018 | Siemens Medical Solutions USA, Inc Artis zee biplane MN, Material no. 10094143, for angiography and whole body radiographic/fluoroscopic procedures. Terminated |
OWB | K141574 |
| May 1, 2018 | Siemens Medical Solutions USA, Inc Artis zee biplane, Material no. 10094141, for angiography and whole body radiographic/fluoroscopic procedures. Terminated |
OWB | K141574 |
| May 1, 2018 | Siemens Medical Solutions USA, Inc Artis Q.zen floor, Material no. 10848353, for angiography and whole body radiographic/fluoroscopic procedures. Terminated |
OWB | K123529 |
| May 1, 2018 | Siemens Medical Solutions USA, Inc Artis Q.zeego, Material no. 10848283, for angiography and whole body radiographic/fluoroscopic procedures. Terminated |
OWB | K123529 |
| May 1, 2018 | Siemens Medical Solutions USA, Inc Artis Q.zen biplane, Material no. 10848355, for angiography and whole body radiographic/fluoroscopic procedures. Terminated |
OWB | K123529 |
| May 1, 2018 | Siemens Medical Solutions USA, Inc Artis Q ceiling, Material no. 10848281, for angiography and whole body radiographic/fluoroscopic procedures. Terminated |
OWB | K123529 |
| May 1, 2018 | Siemens Medical Solutions USA, Inc Artis Q biplane, Material no. 10848282, for angiography and whole body radiographic/fluoroscopic procedures. Terminated |
OWB | K123529 |
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