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Panels › Radiology › Product code IZH · Class 2

System, X-Ray, Mammographic

Regulation 892.1710

0510(k)s in 12 months (176 all time)
0recalls in 12 months (14 all time)
12recalls that name a 510(k)
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Top companies in IZH

Company510(k)sRecalls
Lorad Corp.110
Planmed OY110
Elscint, Inc.100
Fischer Imaging Corp.81
Bennett X-Ray Corp.70
General Electric Med Systems07
Hologic61
Instrumentarium Imaging, Inc.60
Siemens Medical Solutions USA, Inc.60
Lorad, A Hologic Co.50
DateFirm and productCodeLinked 510(k)
Jun 3, 2014Hologic, Inc.
Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.
Terminated		 IZHK011987
Jul 2, 2012Beekley Corporation
Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remove the cold by placing this sheet between the patients breast a
Terminated		 IZHK073262
Sep 26, 2008GE Healthcare
GE Stereotaxy Positioner, model 2405544-3, for use with Senographe DS Full Field Mammography system, models 2383168, 2383168-2, 2383168-3, 2383168-3-1, 2383168-4-1. The expected use of the Senograph
Terminated		 IZHK941191
K990066
Sep 26, 2008GE Healthcare
GE Stereotaxy Positioner, model 2405544-2, for use with Senographe DS Full Field Mammography system, models 2383168, 2383168-2, 2383168-3, 2383168-3-1, 2383168-4-1. The expected use of the Senograph
Terminated		 IZHK941191
K990066
Jun 28, 2007General Electric Med Systems LLC
Diamond Mammographic X-Ray System, type MGX-2000, model 5111771. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A.
Terminated		 IZHK000976
Jan 5, 2005Fischer Imaging Corporation
MammoTest Breast Biopsy System.
Terminated		 IZHK861692
Aug 11, 2004Lorad, A Division of Hologic
Lorad MIV Platinum Mammograpgy System
Terminated		 IZHK011987
Aug 11, 2004Lorad, A Division of Hologic
Lorad M-IV Mammography System
Terminated		 IZHK011987
Jul 20, 2004General Electric Med Systems
Seneographe 600 Mammography X-Ray Systems (all versions)
Terminated		 IZHK881882
Jul 20, 2004General Electric Med Systems
Seneographe 500 Mammography X-Ray Systems (all versions)
Terminated		 IZHNone listed
Jul 20, 2004General Electric Med Systems
Seneographe 800T Mammography X-Ray Systems
Terminated		 IZHK953250
Jul 20, 2004General Electric Med Systems
Seneographe 700T Mammography X-Ray Systems
Terminated		 IZHK953250
Jul 20, 2004General Electric Med Systems
Seneographe DMR Mammography X-Ray System (all versions)
Terminated		 IZHK913418
Jul 20, 2004General Electric Med Systems
Seneographe 2000D Digital Mammography X-Ray System
Terminated		 IZHNone listed

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