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 |
|---|---|---|---|
| Apr 19, 2011 | K093581 | DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS Ge Medical Systems, LLC | JAK |
| Apr 12, 2011 | K110366 | SYNGO.CT CARDIAC FUNCTION Siemens AG | JAK |
| Apr 8, 2011 | K101888 | SCENARIA WHOLE-BODY X-RAY CT SYSTEM Hitachi Medical Systems America, Inc. | JAK |
| Mar 24, 2011 | K102677 | BODYTOM NL 4000 Neurologica Corporation | JAK |
| Mar 11, 2011 | K102102 | COMPUTED TOMOGRAPHY X-RAY SYSTEM VATECH Co., Ltd. | JAK |
| Mar 4, 2011 | K103127 | SOMATOM DEFINITION AS Siemens Medical Solutions USA, Inc. | JAK |
| Feb 18, 2011 | K102259 | DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM VATECH Co., Ltd. | JAK |
| Feb 11, 2011 | K110093 | SUPERDIMENSION MARKER DELIVERY KIT Superdimension, Inc. | JAK |
| Nov 18, 2010 | K093891 | AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2 Toshibamedical Systems Corporation | JAK |
| Oct 7, 2010 | K102604 | I-LOGIC INREACH SYSTEM Superdimension, Ltd. | JAK |
| Aug 4, 2010 | K091529 | ICAD VERALOOK CTC CAD SOFTWARE Icad, Inc. | JAK |
| Jun 18, 2010 | K093810 | BF-NAVI Kgt, Inc. | JAK |
| May 26, 2010 | K100637 | SYNGO.CT CORONARY ANALYSIS Siemens AG Medical Solutions, DE | JAK |
| Mar 11, 2010 | K093787 | IGUIDE CAPPA Cas Innovations GmbH & Co. KG, NL | JAK |
| Jan 27, 2010 | K093995 | IG 4 IMAGE GUIDED SYSTEM Veran Medical Technologies, Inc. | JAK |
| Dec 2, 2009 | K091934 | IG4 ENDOBRONCHIAL, MODEL SYS-0200, NAVIGATION GUIDEWIRE (ACCESSORY TO IG4 ENDOBRONCHIAL), MODEL INS-0300 Veran Medical Technologies, Inc. | JAK |
| Nov 30, 2009 | K093146 | IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200 Veran Medical Technologies, Inc. | JAK |
| Oct 9, 2009 | K092747 | PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL Philips Medical Systems (Cleveland), Inc. | JAK |
| Oct 9, 2009 | K090991 | COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO E-Woo Technology | JAK |
| Sep 22, 2009 | K092742 | NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM Neusoft Medical Systems Co., Ltd., CN | JAK |
| Sep 4, 2009 | K092365 | INREACH SYSTEM, MODEL AAS00161-02 Superdimension, Ltd. | JAK |
| Jul 17, 2009 | K092013 | SYNGO VOLUME PERFUSION-CT BODY Siemens AG Medical Solutions, DE | JAK |
| Jun 24, 2009 | K091673 | GE LIGHTSPEED ACT FP16 Ge Medical Systems, Inc. | JAK |
| Jun 23, 2009 | K090462 | BRILLIANCE DUAL ENERGY OPTION Philips Medical Systems (Cleveland), Inc. | JAK |
| Jun 15, 2009 | K091103 | GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS Hitachi Medical Systems America, Inc. | JAK |
| May 27, 2009 | K091195 | PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511 Philips Medical Systems (Cleveland), Inc. | JAK |
| Apr 1, 2009 | K083524 | SYNGO DUAL ENERGY WITH EXTENDED FUNATIONALLY Siemens Medical Solutions USA, Inc. | JAK |
| Mar 5, 2009 | K090504 | CSBP-001A BODY PERFUSION SYSTEM Toshibamedical Systems Corporation | JAK |
| Feb 11, 2009 | K090220 | COLON VIEW, MODEL CSCV-001A Toshibamedical Systems Corporation | JAK |
| Feb 5, 2009 | K090173 | NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM Neusoft Medical Systems Co., Ltd., CN | JAK |
| Dec 17, 2008 | K083498 | PHILIPS MODEL MX 16 SLICE CT SYSTEM Philips Medical Systems (Cleveland), Inc. | JAK |
| Dec 12, 2008 | K083282 | MODEL TSX-301B AQUILION CT SYSTEM Toshiba America Medical Systems, In.C | JAK |
| Dec 5, 2008 | K083293 | VIATRONIX V3D-CARDIAC, REVISION 1.0 Viatronix, Inc. | JAK |
| Nov 18, 2008 | K083227 | VIDA PULMONARY WORKSTATION 2 (PW2) Vida Diagnostics, Inc. | JAK |
| Oct 17, 2008 | K082960 | GE XTREME INJECTOR OPTION Ge Medical Systems, LLC | JAK |
| Oct 17, 2008 | K082458 | P3T ABDOMEN Medrad, Inc. | JAK |
| Oct 16, 2008 | K080581 | VB IMAGE VIEWER Olympus Medical Systems Corporation | JAK |
| Oct 10, 2008 | K082220 | SOMATOM FLASH DS Siemens Medical Solutions USA, Inc. | JAK |
| Oct 8, 2008 | K082816 | GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM Ge Medical Systems, LLC | JAK |
| Oct 8, 2008 | K082761 | GE LIGHTSPEED 7.2 CT SCANNER SYSTEM Ge Medical Systems, LLC | JAK |
| Sep 2, 2008 | K082104 | GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM Ge Medical Systems, Inc. | JAK |
| Aug 21, 2008 | K081847 | PICASSO MASTER, ECT AND MASTER 3D E-Woo Technology | JAK |
| Jun 11, 2008 | K081482 | CSBP-001A BODY ORGAN PERFUSION SYSTEM Toshiba America Medical Systems, In.C | JAK |
| Jun 11, 2008 | K081379 | MODIFICATION TO INREACH SYSTEM Superdimension, Ltd. | JAK |
| Jun 2, 2008 | K081022 | SOMATOM DEFINITION, MODEL AS/AS+ Siemens Medical Solutions USA, Inc. | JAK |
| May 9, 2008 | K081105 | GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0) GE Healthcare | JAK |
| Apr 11, 2008 | K080624 | NAVSTATIONIRAD EMT, VERSION 1.1 Cas Innovations AG, DE | JAK |
| Apr 9, 2008 | K073695 | 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17 J. Morita USA, Inc. | JAK |
| Mar 31, 2008 | K080271 | INREACH SYSTEM Superdimension, Ltd. | JAK |
| Mar 21, 2008 | K073346 | ZIEHM VISION 2 Ziehm Imaging, Inc. | JAK |
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