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Panels › Radiology › Product code JAK · Class 2

System, X-Ray, Tomography, Computed

Regulation 892.1750

22510(k)s in 12 months (827 all time)
38recalls in 12 months (872 all time)
795recalls that name a 510(k)
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Top companies in JAK

DateFirm and productCodeLinked 510(k)
Jan 23, 2009Siemens Medical Solutions USA, Inc
Somatom Definition AS, Model number 8098027. Computed tomography x-ray system
Terminated
JAKK081022
Jan 8, 2009Hitachi Medical Systems America Inc
Hitachi CXR4 Computed Tomography Scanner. This product is an x-ray imaging device that produces cross-sectional images of he body at different angles. The system reconstructs, processes, displays, an
Terminated
JAKK040902
Jan 5, 2009Siemens Medical Solutions USA, Inc
Somatom Sensation 64 X-Ray System, Model number 8377520. This is a computed tomography x-ray system which is intended to produce cross-sectional images of the body by computer reconstruction of x-ray
Terminated
JAKK040665
Jan 5, 2009Siemens Medical Solutions USA, Inc
Somatom Sensation 40 X-Ray System, Model number 8874427. This is a computed tomography x-ray system which is intended to produce cross-sectional images of the body by computer reconstruction of x-ray
Terminated
JAKK040665
Sep 29, 2008Toshiba American Med Sys Inc
Toshiba America Medical Systems (TAMS) Aquilion 64 CT system, computed tomography x-ray system.
Terminated
JAKK982265
Sep 29, 2008Toshiba American Med Sys Inc
Toshiba America Medical Systems (TAMS) Aquilion 32 CT system, computed tomography x-ray system.
Terminated
JAKK982265
Sep 21, 2008Siemens Medical Solutions USA, Inc
SOMATOM Emotion 16. Computed tomography X-ray system
Terminated
JAKK050297
Sep 21, 2008Siemens Medical Solutions USA, Inc
SOMATOM Emotion 6. Computed tomography X-ray system
Terminated
JAKK023687
Sep 17, 2008Philips And Neusoft Medical Systems Co., Ltd.
NeuViz Dual series computed Tomography Scanner System, X-Ray System
Terminated
JAKK062451
K071308
Sep 17, 2008Philips And Neusoft Medical Systems Co., Ltd.
NeuViz Dual series computed Tomography Scanner System, X-Ray System The CT scanner is a whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and fun
Terminated
JAKK062451
K071308
Sep 1, 2008Imaging Sciences Intl Inc
i-CAT Classic 3D Dental Imaging System
Terminated
JAKK051980
Feb 7, 2008Xoran Technologies, Inc.
Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI
Terminated
JAKK032243
Dec 29, 2007Philips Medical Systems (Cleveland) Inc
Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on all Brilliance CT scanners using software versions 2.0 through V 2.2.5 and all EBW workstations using software v
Terminated
JAKNone listed
Dec 29, 2007Philips Medical Systems (Cleveland) Inc
Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on all Gemini TFs, GXLs and EBW Workstations. Philips Medical Systems, Cleveland, OH 44143. (The product is a soft
Terminated
JAKK012009
K033326 +1
Nov 27, 2007Xoran Technologies, Inc.
Xoran MiniCAT for ENT, Xoran Technologies, Incorporated, Ann Arbor, MI 48103. This device is a cone beam CT scan for sinue, temporal bones and maxillofacial imaging.
Terminated
JAKK032243
Nov 21, 2007Philips Medical Systems (Cleveland) Inc
Philips, Voxel Q workstations, untilizing AcQSim or AcQPlan software version 4.2, 4.2.1, 4.9, 4.9.1, 4.9.2, 4.9.3, 5.0, 5.0.1, 5.0.2 or 5.0.3 and any Mx8000, Mx8001DT, or Brilliance 6, 10, 16, 16P
Terminated
JAKK884268
Nov 7, 2007Philips Medical Systems (Cleveland) Inc
The Brilliance CT Big Bore is a whole body computed tomography X-Ray system. The malfunctioning software application is the Tumor Localization (Tumor LOC) application.
Terminated
JAKK033357
Oct 31, 2007Philips Medical Systems (Cleveland) Inc
Brilliance CT Systems 64 slice configuration. Computed tomography scanner.
Terminated
JAKK033326
Oct 31, 2007Philips Medical Systems (Cleveland) Inc
Brilliance CT Systems, 40 slice configuration. Computed tomography scanner.
Terminated
JAKK033326
Sep 13, 2007Philips Medical Systems (Cleveland) Inc
The product is an isolation transformer, an accessory to Computed Tomography Scanner. It consists of electronic circuitry enclosed in a metal case. According to Philips Medical Systems, the metal ca
Terminated
JAKNone listed
May 15, 2007GE Healthcare
GE Discovery VCT, Volume PET-CT scanner, Model 5124069-3.
Terminated
JAKK050559
May 15, 2007GE Healthcare
GE LightSpeed Xtra / GE LightSpeed RT Pro 16, Model 2374681-6, CT Scanner systems.
Terminated
JAKK060052
May 15, 2007GE Healthcare
GE LightSpeed Pro 16 (100kW/80kW) Models 2357739, 2357739-3, 2357739-4, 2357739-6, 2357739-7 and 2357739-8, CT Scanner systems
Terminated
JAKK030420
May 15, 2007GE Healthcare
GE LightSpeed VCT Select / LightSpeed Pro32, Model 5126093, CT Scanner system.
Terminated
JAKK040372
May 15, 2007GE Healthcare
GE LightSpeed VCT / Light Speed VCT standard configuration, Model 5124069, CT Scanner System.
Terminated
JAKK040372
Mar 29, 2007SuperDimension, Inc.
Disposable components of the superDimension Bronchus System: Locatable Guide Kit (AKI00017-01) and Extended Working Channel (AKI00041-01).
Terminated
JAKNone listed
Mar 29, 2007SuperDimension, Inc.
superDimension Bronchus System (AAS00016-01), an image-guided localization system used to guide endoscopic tools to predetermined targets within the pulmonary tract.
Terminated
JAKK042438
K052260 +2
Feb 23, 2007Siemens Medical Solutions USA, Inc.
Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System with a Pinhole Collimator; Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barringt
Terminated
JAKK041166
Feb 15, 2007GE Healthcare
The LightSpeed VCT System is intended for head and whole body X-ray Computed Tomography applications.
Terminated
JAKK040372
Feb 15, 2007GE Healthcare
The LightSpeed RT16 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. The system is capable of generating images for the guidance of minimally invasive pr
Terminated
JAKK060052
Oct 12, 2006Becton Dickinson & Company
BD Vacutainer Push Button Blood Collection Set with Pre-attached Holder. Non-pyrogenic 100. Rx only, sterile REF 368656 23G x 3/4'' x 12'' 0.6 x 19mm x 305mm ----- REF 367352 21G x 3/4'' x 12
Terminated
JAKK011984
Jun 3, 2006Hitachi Medical Systems America Inc
Hitachi Emission Computed Tomography System Hitachi CX-4 CT (including SceptreP3 PET-CT)
Terminated
JAKK040902
K042428
Jun 3, 2006Hitachi Medical Systems America Inc
Hitachi CXR-4 CT Computed Tomography X-ray System (including SceptreP3 PET/CT)
Terminated
JAKK040902
K042428
Apr 26, 2006Siemens Medical Solutions USA, Inc
SOMATOM CT System Sensation Open. Computed tomography x-ray system.
Terminated
JAKK040577
Apr 26, 2006Siemens Medical Solutions USA, Inc
SOMATOM CT System Sensation 40 and Sensation 64. Computed tomography x-ray system.
Terminated
JAKK040665
Apr 26, 2006Siemens Medical Solutions USA, Inc
SOMATOM CT System Sensation 16. Computed tomography x-ray system.
Terminated
JAKK013522
Apr 26, 2006Siemens Medical Solutions USA, Inc
SOMATOM Sensation CT Systems
Terminated
JAKNone listed
Apr 26, 2006Siemens Medical Solutions USA, Inc
SOMATOM CT System Emotion 16. Computed tomography x-ray system.
Terminated
JAKK050297
Jan 25, 2006Siemens Medical Solutions USA, Inc
Arcadis Varic Mobile X-ray System
Terminated
JAKK040066
Jan 25, 2006Siemens Medical Solutions USA, Inc
Arcadis Orbic Mobile X-Ray System
Terminated
JAKK042793
Oct 25, 2005Medrad Inc
Medrad Overhead Counterpoise System II. Support Arm. Mount Injector Head. Catalog numbers 3010544, 3010545, 3010546, 3010547, 3010548, 3010549, 3010550, 3010551, 3010552, and 3010553.
Terminated
JAKK944983
Oct 21, 2005Philips Medical Systems (Cleveland) Inc
Gemini GXL PET/CT Systems, 6, 10, 16 slice configurations. (Product Numbers/manufacturer numbers: 16 slice: 4535 679 71891, 10 slice: 4535 679 75691, 6 slice: 4535 679 75691. Catalog numbers: 16 slice
Terminated
JAKK042935
Aug 31, 2005Philips Medical Systems North America Co. Phillips
Interis Allura BiPlane X-Ray System
Terminated
JAKK002016
Aug 30, 2005Philips Medical Systems (Cleveland) Inc
Gemini 16 PET/CT sytem, Slice Configuration
Terminated
JAKK032036
Aug 30, 2005Philips Medical Systems (Cleveland) Inc
Gemini PET/CT sytem, Dual Configuration
Terminated
JAKK013521
Aug 30, 2005Philips Medical Systems (Cleveland) Inc
MxView using version 5.0, 5.0.1, or 4.1 software.
Terminated
JAKK012009
Aug 30, 2005Philips Medical Systems (Cleveland) Inc
Extended Brilliance Workspace using 1.x or 2.x software.
Terminated
JAKK012009
Aug 30, 2005Philips Medical Systems (Cleveland) Inc
MX8000 Dual v.EXP CT scanner using Version 2.5 software.
Terminated
JAKK010817
Aug 30, 2005Philips Medical Systems (Cleveland) Inc
MX8000IDT CT Scanner using version 2.5.5, 3.0, 3.1, 3.2, 3.2.2, or 3.2.4 software.
Terminated
JAKNone listed
Aug 30, 2005Philips Medical Systems (Cleveland) Inc
Brillance CT System, 16, 10 and 6 configurations (air cooled version) using version 1.2 or 1.2.1software.
Terminated
JAKK010817

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