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
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 14, 2008 | K080211 | MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM Toshiba America Medical Systems, In.C | JAK |
| Mar 13, 2008 | K080540 | NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0 Neusoft Medical Systems Co., Ltd., CN | JAK |
| Feb 26, 2008 | K073153 | CARDIQ FUNCTION XPRESS GE Medical Systems SCS, FR | JAK |
| Feb 26, 2008 | K073138 | CARDIQ EXPRESS VERSION 2.0 GE Medical Systems | JAK |
| Feb 7, 2008 | K073003 | SYNGO DUAL ENERGY WITH EXTENDED FUNCTIONALLY Siemens Medi Cal Solutions, Inc. | JAK |
| Jan 3, 2008 | K073238 | SYNGO VOLUME PERFUSION-CT NEURO Siemens AG Medical Solutions, DE | JAK |
| Dec 18, 2007 | K073373 | SYNGO VOLUME PERFUSION-CT BODY Siemens AG Medical Solutions, DE | JAK |
| Nov 1, 2007 | K072693 | CSNP-001A NEURO PACKAGE Toshiba America Medical Systems, In.C | JAK |
| Oct 18, 2007 | K072574 | ALPHARD CONE BEAM CT, MODEL X178 Takara Belmont Corp. | JAK |
| Oct 16, 2007 | K072841 | NEUVIZ SPIRAL CT SCANNER SYSTEM Neusoft Medical Systems Co., Ltd., CN | JAK |
| Oct 5, 2007 | K072737 | CSCS-001A CALCIUM SCORING PACKAGE Toshiba America Medical Systems, In.C | JAK |
| Oct 2, 2007 | K072606 | AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM Toshiba America Medical Systems, In.C | JAK |
| Aug 28, 2007 | K071806 | ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM Hitachi Medical Systems America, Inc. | JAK |
| Aug 16, 2007 | K071308 | MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM Neusoft Medical Systems Co., Ltd., CN | JAK |
| Jun 26, 2007 | K071513 | INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY Siemens Medical Solutions, DE | JAK |
| Jun 13, 2007 | K071378 | MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES E-Z-Em, Inc. | JAK |
| Jun 8, 2007 | K071310 | SYNGO CT ONCOLOGY SOFTWARE PACKAGE Siemens AG, DE | JAK |
| Apr 5, 2007 | K070658 | DENTAL DIGITAL PANORAMIC/3D IMAGING SYSTEM E-Woo Technology | JAK |
| Mar 23, 2007 | K063324 | PET VCAR GE Healthcare | JAK |
| Jan 5, 2007 | K063762 | SYNGO CIRCULATION SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY Siemens AG Medical Solutions, DE | JAK |
| Nov 30, 2006 | K063507 | SYNGO NEURO PBV CT Siemens AG, DE | JAK |
| Nov 9, 2006 | K063241 | CSTC-002A, EXTENDED FIELD OF VIEW SOFTWARE OPTION Toshiba America Medical Systems, In.C | JAK |
| Nov 3, 2006 | K063189 | TSX-301A, AQUILION ONE CT SYSTEM Toshiba America Medical Systems, In.C | JAK |
| Nov 3, 2006 | K063184 | MODEL CVV-001A VESSEL VIEW SOFTWARE OPTION Toshiba America Medical Systems, In.C | JAK |
| Nov 2, 2006 | K063029 | EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 E-Z-Em, Inc. | JAK |
| Oct 5, 2006 | K062386 | QANGIO CT Medis Medical Imaging Systems BV, NL | JAK |
| Oct 5, 2006 | K062351 | SYNGO DUAL ENERGY Siemens Medical Solutions USA, Inc. | JAK |
| Sep 28, 2006 | K062451 | NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM Neusoft Medical Systems Co., Ltd., CN | JAK |
| Sep 22, 2006 | K062673 | MODIFICATION TO SYNGO INSPACE 4D Siemens AG Medical Solutions, DE | JAK |
| Sep 8, 2006 | K062315 | SUPERDIMENSION/BRONCHUS PREMIUM 2 Superdimension, Ltd. | JAK |
| Aug 7, 2006 | K061834 | XCAT; XCAT FOR NEURO Xoran Technologies, Inc. | JAK |
| Jul 25, 2006 | K061449 | SYNGO EXPERT-1 Siemens Medical Solution | JAK |
| Jul 12, 2006 | K061817 | LIGHTSPEED 7.1 CT SCANNER SYSTEM Ge Medical Systems, LLC | JAK |
| Jul 7, 2006 | K061310 | ZIEHM VARIO 3D DIGITAL MOBILE IMAGING SYSTEM Ziehm Imaging, Inc. | JAK |
| Jun 26, 2006 | K061625 | AUTOBONE2 GE Healthcare | JAK |
| Jun 5, 2006 | K060937 | BRILLIANCE VOLUME Philips Medical Systems (Cleveland), Inc. | JAK |
| May 30, 2006 | K061370 | CARDIQ FUSION GE Healthcare | JAK |
| May 12, 2006 | K061187 | TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING Toshiba America Medical Systems, In.C | JAK |
| May 11, 2006 | K060903 | IG4 IMAGE GUIDED SYSTEM Veran Medical Technologies, Inc. | JAK |
| Apr 19, 2006 | K060052 | GE LIGHTSPEED XTRA CT SCANNER SYSTEM Ge Medical Systems, LLC | JAK |
| Apr 19, 2006 | K053610 | ABARIS Traxtal Technologies, Inc., CA | JAK |
| Apr 5, 2006 | K060779 | ADVANCE VESSEL ANALYSIS II GE Healthcare | JAK |
| Mar 10, 2006 | K052839 | CT PERFUSION 4 GE Healthcare | JAK |
| Feb 17, 2006 | K053148 | CXR16 Hitachi Medical Systems America, Inc. | JAK |
| Jan 6, 2006 | K053210 | MAYFIELD SCANMATE MOBILE CT SYSTEM Schaerer Mayfield USA, Inc. | JAK |
| Dec 27, 2005 | K052587 | 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1 EXF J. Morita USA, Inc. | JAK |
| Nov 14, 2005 | K052852 | SUPERDIMENSION/BRONCHUS PREMIUM Superdimension, Ltd. | JAK |
| Nov 8, 2005 | K053046 | ILUMA ORTHOCAT/DENTALCAT Imtec Corp. | JAK |
| Nov 4, 2005 | K053024 | SYNGO NEURO DSA CT Siemens AG, DE | JAK |
| Oct 28, 2005 | K052855 | STARSPEED SERIES CT SCANNER SYSTEMS GE Healthcare | JAK |
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