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Panels › Radiology › Product code IZO · Class 1

Generator, High-Voltage, X-Ray, Diagnostic

Regulation 892.1700

0510(k)s in 12 months (163 all time)
0recalls in 12 months (5 all time)
2recalls that name a 510(k)
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Top companies in IZO

Company510(k)sRecalls
Fischer Imaging Corp.220
General Electric Co.120
Shimadzu Medical Systems101
Electromed Intl., Ltd.80
Siemens Corp.60
Continental X-Ray Corp.50
Control-X, Inc.50
Philips Medical Systems (Cleveland), Inc.50
Siemens Medical Solutions USA, Inc.50
Varian Canada, Inc.50
DateFirm and productCodeLinked 510(k)
Nov 20, 2016Shimadzu Medical Systems
Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube Diagnostic x-ray high voltage generator.
Terminated		 IZONone listed
Mar 4, 2011Philips Healthcare Inc.
BuckyDiagnost general purpose x-ray system with Optimus Generator. General Purpose Diagnostic Radiography.
Terminated		 IZONone listed
Jun 25, 2010Mallinckrodt Inc
Hydradjust IV DR Urological Table Sedecal Generator (p/n 750732 - 64W generator & p/n 750733 80W generator). Mallinckrodt, Inc. Cincinnati, OH 45237. Facilitates digital radiologic and/or fluoroscop
Terminated		 IZOK920742
K943581
Oct 27, 2008GE Healthcare
Monitor suspensions used with Advantx Legacy, RFX Classical, SFX-90, Model # 46-240838G2, manufactured after March 8, 1985 for Advantx Legacy, RFX and SFX systems. General-purpose radiographic system
Terminated		 IZOK760466
K801320 +1
Apr 25, 2003Sedecal USA, Inc.
Sedecal X-Ray High Voltage Generators and Controls; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN
Terminated		 IZONone listed

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