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Panels › Radiology › Product code IZI · Class 2

System, X-Ray, Angiographic

Regulation 892.1600

2510(k)s in 12 months (199 all time)
1recalls in 12 months (259 all time)
240recalls that name a 510(k)
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Top companies in IZI

Company510(k)sRecalls
Siemens Medical Solutions USA, Inc.1398
Philips Medical Systems North America Co. Phillips055
Philips Electronics North America Corporation034
GE Healthcare226
GE Medical Systems103
Shimadzu Medical Systems85
Novadaq Technologies, Inc.93
Philips Medical Systems64
Xre Corp.100
Philips Medical Systems North America Co.90
DateFirm and productCodeLinked 510(k)
Jul 20, 2004General Electric Med Systems
Advantx 1 SC Model 36006617 Angiographic X-ray System
Terminated		 IZIK890348
Jul 20, 2004General Electric Med Systems
Advantx 1 LC2 Model 2105657 Angiographic X-ray System
Terminated		 IZIK890348
Jul 20, 2004General Electric Med Systems
Advantx 1 LC2 Model 45562281 Angiographic X-ray System
Terminated		 IZIK890348
Jul 20, 2004General Electric Med Systems
Advantx 1 LC1 Model 45258230 Angiographic X-ray System
Terminated		 IZIK890348
Jul 20, 2004General Electric Med Systems
Advantx 1 LC1 Model 46-279781P1 Angiographic X-ray System
Terminated		 IZIK890348
Jul 20, 2004Philips Medical Systems Sales & Service Region No. America
Monitor Ceiling Suspension for Fluoroscopic and Angiographic X-Ray Systems.
Terminated		 IZIK912470
K923813
Jul 20, 2004Siemens Medical Solutions USA, Inc
Axiom Artis System
Terminated		 IZIK010721
Jul 19, 2003Siemens Medical Solutions USA, Inc
Cathcor/LX/Desktop, System, X-Ray, Angiographic
Terminated		 IZIK002137
Dec 18, 2002Siemens Medical Systems Inc
Axiom Artis System, X-ray, Angiographic
Terminated		 IZIK010721

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