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)
Top companies in JAK
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2009 | Siemens Medical Solutions USA, Inc Somatom Definition AS, Model number 8098027.
Computed tomography x-ray system Terminated |
JAK | K081022 |
| Jan 8, 2009 | Hitachi 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 |
JAK | K040902 |
| Jan 5, 2009 | Siemens 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 |
JAK | K040665 |
| Jan 5, 2009 | Siemens 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 |
JAK | K040665 |
| Sep 29, 2008 | Toshiba American Med Sys Inc Toshiba America Medical Systems (TAMS) Aquilion 64 CT system, computed tomography x-ray system. Terminated |
JAK | K982265 |
| Sep 29, 2008 | Toshiba American Med Sys Inc Toshiba America Medical Systems (TAMS) Aquilion 32 CT system, computed tomography x-ray system. Terminated |
JAK | K982265 |
| Sep 21, 2008 | Siemens Medical Solutions USA, Inc SOMATOM Emotion 16. Computed tomography X-ray system Terminated |
JAK | K050297 |
| Sep 21, 2008 | Siemens Medical Solutions USA, Inc SOMATOM Emotion 6. Computed tomography X-ray system Terminated |
JAK | K023687 |
| Sep 17, 2008 | Philips And Neusoft Medical Systems Co., Ltd. NeuViz Dual series computed Tomography Scanner System, X-Ray System Terminated |
JAK | K062451 K071308 |
| Sep 17, 2008 | Philips 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 |
JAK | K062451 K071308 |
| Sep 1, 2008 | Imaging Sciences Intl Inc i-CAT Classic 3D Dental Imaging System Terminated |
JAK | K051980 |
| Feb 7, 2008 | Xoran Technologies, Inc. Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI Terminated |
JAK | K032243 |
| Dec 29, 2007 | Philips 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 |
JAK | None listed |
| Dec 29, 2007 | Philips 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 |
JAK | K012009 K033326 +1 |
| Nov 27, 2007 | Xoran 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 |
JAK | K032243 |
| Nov 21, 2007 | Philips 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 |
JAK | K884268 |
| Nov 7, 2007 | Philips 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 |
JAK | K033357 |
| Oct 31, 2007 | Philips Medical Systems (Cleveland) Inc Brilliance CT Systems 64 slice configuration. Computed tomography scanner. Terminated |
JAK | K033326 |
| Oct 31, 2007 | Philips Medical Systems (Cleveland) Inc Brilliance CT Systems, 40 slice configuration. Computed tomography scanner. Terminated |
JAK | K033326 |
| Sep 13, 2007 | Philips 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 |
JAK | None listed |
| May 15, 2007 | GE Healthcare GE Discovery VCT, Volume PET-CT scanner, Model 5124069-3. Terminated |
JAK | K050559 |
| May 15, 2007 | GE Healthcare GE LightSpeed Xtra / GE LightSpeed RT Pro 16, Model 2374681-6, CT Scanner systems. Terminated |
JAK | K060052 |
| May 15, 2007 | GE Healthcare GE LightSpeed Pro 16 (100kW/80kW) Models 2357739, 2357739-3, 2357739-4, 2357739-6, 2357739-7 and 2357739-8, CT Scanner systems Terminated |
JAK | K030420 |
| May 15, 2007 | GE Healthcare GE LightSpeed VCT Select / LightSpeed Pro32, Model 5126093, CT Scanner system. Terminated |
JAK | K040372 |
| May 15, 2007 | GE Healthcare GE LightSpeed VCT / Light Speed VCT standard configuration, Model 5124069, CT Scanner System. Terminated |
JAK | K040372 |
| Mar 29, 2007 | SuperDimension, Inc. Disposable components of the superDimension Bronchus System: Locatable Guide Kit (AKI00017-01) and Extended Working Channel (AKI00041-01). Terminated |
JAK | None listed |
| Mar 29, 2007 | SuperDimension, Inc. superDimension Bronchus System (AAS00016-01), an image-guided localization system used to guide endoscopic tools to predetermined targets within the pulmonary tract. Terminated |
JAK | K042438 K052260 +2 |
| Feb 23, 2007 | Siemens 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 |
JAK | K041166 |
| Feb 15, 2007 | GE Healthcare The LightSpeed VCT System is intended for head and whole body X-ray Computed Tomography applications. Terminated |
JAK | K040372 |
| Feb 15, 2007 | GE 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 |
JAK | K060052 |
| Oct 12, 2006 | Becton 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 |
JAK | K011984 |
| Jun 3, 2006 | Hitachi Medical Systems America Inc Hitachi Emission Computed Tomography System
Hitachi CX-4 CT (including SceptreP3 PET-CT) Terminated |
JAK | K040902 K042428 |
| Jun 3, 2006 | Hitachi Medical Systems America Inc Hitachi CXR-4 CT Computed Tomography X-ray System (including SceptreP3 PET/CT) Terminated |
JAK | K040902 K042428 |
| Apr 26, 2006 | Siemens Medical Solutions USA, Inc SOMATOM CT System Sensation Open. Computed tomography x-ray system. Terminated |
JAK | K040577 |
| Apr 26, 2006 | Siemens Medical Solutions USA, Inc SOMATOM CT System Sensation 40 and Sensation 64. Computed tomography x-ray system. Terminated |
JAK | K040665 |
| Apr 26, 2006 | Siemens Medical Solutions USA, Inc SOMATOM CT System Sensation 16. Computed tomography x-ray system. Terminated |
JAK | K013522 |
| Apr 26, 2006 | Siemens Medical Solutions USA, Inc SOMATOM Sensation CT Systems Terminated |
JAK | None listed |
| Apr 26, 2006 | Siemens Medical Solutions USA, Inc SOMATOM CT System Emotion 16. Computed tomography x-ray system. Terminated |
JAK | K050297 |
| Jan 25, 2006 | Siemens Medical Solutions USA, Inc Arcadis Varic Mobile X-ray System Terminated |
JAK | K040066 |
| Jan 25, 2006 | Siemens Medical Solutions USA, Inc Arcadis Orbic Mobile X-Ray System Terminated |
JAK | K042793 |
| Oct 25, 2005 | Medrad 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 |
JAK | K944983 |
| Oct 21, 2005 | Philips 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 |
JAK | K042935 |
| Aug 31, 2005 | Philips Medical Systems North America Co. Phillips Interis Allura BiPlane X-Ray System Terminated |
JAK | K002016 |
| Aug 30, 2005 | Philips Medical Systems (Cleveland) Inc Gemini 16 PET/CT sytem, Slice Configuration Terminated |
JAK | K032036 |
| Aug 30, 2005 | Philips Medical Systems (Cleveland) Inc Gemini PET/CT sytem, Dual Configuration Terminated |
JAK | K013521 |
| Aug 30, 2005 | Philips Medical Systems (Cleveland) Inc MxView using version 5.0, 5.0.1, or 4.1 software. Terminated |
JAK | K012009 |
| Aug 30, 2005 | Philips Medical Systems (Cleveland) Inc Extended Brilliance Workspace using 1.x or 2.x software. Terminated |
JAK | K012009 |
| Aug 30, 2005 | Philips Medical Systems (Cleveland) Inc MX8000 Dual v.EXP CT scanner using Version 2.5 software. Terminated |
JAK | K010817 |
| Aug 30, 2005 | Philips 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 |
JAK | None listed |
| Aug 30, 2005 | Philips Medical Systems (Cleveland) Inc Brillance CT System, 16, 10 and 6 configurations (air cooled version) using version 1.2 or 1.2.1software. Terminated |
JAK | K010817 |
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