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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)
Jun 6, 2019Siemens Medical Solutions USA, Inc
Siemens Artis Q zeego ---Interventional Fluoroscopic X-Ray System Model Number: 10848283
Terminated
OWBK181407
Jun 6, 2019Siemens Medical Solutions USA, Inc
Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282
Terminated
OWBK181407
Jun 6, 2019Siemens Medical Solutions USA, Inc
Siemens Artis Q ceiling--Interventional Fluoroscopic X-Ray System Model Number: 10848281
Terminated
OWBK181407
Jun 6, 2019Siemens Medical Solutions USA, Inc
Siemens Artis Q floor --Interventional Fluoroscopic X-Ray System Model Number: 10848280
Terminated
OWBK181407
Jun 6, 2019Siemens Medical Solutions USA, Inc
Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959
Terminated
OWBK181407
Jun 6, 2019Siemens Medical Solutions USA, Inc
Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System Model Number: 10094141
Terminated
OWBK181407
Jun 6, 2019Siemens Medical Solutions USA, Inc
Siemens Artis zee ceiling -Interventional Fluoroscopic X-Ray System Model Number: 10094137
Terminated
OWBK181407
Jun 6, 2019Siemens Medical Solutions USA, Inc
Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135
Terminated
OWBK181407
Mar 22, 2019Siemens 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
OWBK181560
Mar 18, 2019Siemens 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
OWBK132094
Feb 28, 2019Philips 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
OWBK032046
Feb 8, 2019Siemens 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
OWBK173639
Jan 14, 2019Shimadzu 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
OWBK123508
Nov 30, 2018Philips Medical Systems Nederlands
Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
Terminated
OWBK172822
Nov 2, 2018Stephanix
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
OWBK102529
Oct 19, 2018Siemens 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
OWBK123529
Oct 19, 2018Siemens 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
OWBK123529
Oct 19, 2018Shimadzu 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
OWBK123508
Oct 5, 2018GE Medical Systems, SCS
Discovery IGS 740 Interventional Fluoroscopic X-ray Systems
Terminated
OWBK133278
Oct 5, 2018GE Medical Systems, SCS
Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
Terminated
OWBK111209
K122457
Oct 5, 2018GE Medical Systems, SCS
Discovery IGS 730 Interventional Fluoroscopic X-ray Systems
Terminated
OWBK113403
K122457
Sep 21, 2018Philips 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
OWBK141979
Sep 21, 2018Philips 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
OWBK141979
Sep 21, 2018Philips 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
OWBK141979
Sep 21, 2018Philips 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
OWBK141979
Sep 21, 2018Philips 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
OWBK141979
Sep 21, 2018Philips 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
OWBK141979
Sep 17, 2018Medtronic 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
OWBK173664
Jul 29, 2018Siemens Medical Solutions USA, Inc
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
Terminated
OWBK163286
Jul 29, 2018Siemens Medical Solutions USA, Inc
Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355
Terminated
OWBK123529
Jun 27, 2018Philips Medical Systems Nederlands
OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025
Terminated
OWBK982993
Jun 22, 2018Siemens 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
OWBK163286
Jun 22, 2018Siemens 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
OWBK123529
Jun 11, 2018Philips Healthcare
Centron Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications includin
Terminated
OWBNone listed
Jun 11, 2018Philips Healthcare
UNIQ Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including d
Terminated
OWBNone listed
Jun 11, 2018Philips Healthcare
Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications incl
Terminated
OWBNone listed
May 30, 2018Siemens Medical Solutions USA, Inc
ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
Terminated
OWBK163286
May 25, 2018Siemens 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
OWBK141574
May 1, 2018Siemens Medical Solutions USA, Inc
Artis zeego, Material no. 10280959 , for angiography and whole body radiographic/fluoroscopic procedures.
Terminated
OWBK141574
May 1, 2018Siemens Medical Solutions USA, Inc
Artis zee MP, Material no. 10094139, for angiography and whole body radiographic/fluoroscopic procedures.
Terminated
OWBK141574
May 1, 2018Siemens Medical Solutions USA, Inc
Artis zee floor MN, Material no. 10094142, for angiography and whole body radiographic/fluoroscopic procedures.
Terminated
OWBK141574
May 1, 2018Siemens Medical Solutions USA, Inc
Artis zee floor, Material no. 10094135, for angiography and whole body radiographic/fluoroscopic procedures.
Terminated
OWBK141574
May 1, 2018Siemens Medical Solutions USA, Inc
Artis zee ceiling, Material no. 10094137, for angiography and whole body radiographic/fluoroscopic procedures.
Terminated
OWBK141574
May 1, 2018Siemens Medical Solutions USA, Inc
Artis zee biplane MN, Material no. 10094143, for angiography and whole body radiographic/fluoroscopic procedures.
Terminated
OWBK141574
May 1, 2018Siemens Medical Solutions USA, Inc
Artis zee biplane, Material no. 10094141, for angiography and whole body radiographic/fluoroscopic procedures.
Terminated
OWBK141574
May 1, 2018Siemens Medical Solutions USA, Inc
Artis Q.zen floor, Material no. 10848353, for angiography and whole body radiographic/fluoroscopic procedures.
Terminated
OWBK123529
May 1, 2018Siemens Medical Solutions USA, Inc
Artis Q.zeego, Material no. 10848283, for angiography and whole body radiographic/fluoroscopic procedures.
Terminated
OWBK123529
May 1, 2018Siemens Medical Solutions USA, Inc
Artis Q.zen biplane, Material no. 10848355, for angiography and whole body radiographic/fluoroscopic procedures.
Terminated
OWBK123529
May 1, 2018Siemens Medical Solutions USA, Inc
Artis Q ceiling, Material no. 10848281, for angiography and whole body radiographic/fluoroscopic procedures.
Terminated
OWBK123529
May 1, 2018Siemens Medical Solutions USA, Inc
Artis Q biplane, Material no. 10848282, for angiography and whole body radiographic/fluoroscopic procedures.
Terminated
OWBK123529

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