FDA 510(k) Applications for Medical Device Product Code "JAK"
(System, X-Ray, Tomography, Computed)

FDA 510(k) Number Applicant Device Name Decision Date
K193293 4Dx Limited XV Lung Ventilation Analysis Software 05/14/2020
K012106 ACCUIMAGE DIAGNOSTICS CORP. ACCUIMAGE SMARTGATE UPGRADE 09/25/2001
K024149 ACCUIMAGE DIAGNOSTICS CORP. PRIMELUNG 02/21/2003
K110812 ACTIVIEWS LTD CT-GUIDE NEEDLE GUIDANCE SYSTEM 06/21/2011
K113063 ACTIVIEWS LTD CT-GUIDE NEEDLE GUIDANCE SYSTEM 11/10/2011
K120300 ACTIVIEWS LTD CT-GUIDE NEEDLE GUIDANCE SYSTEM 04/13/2012
K013521 ADAC LABORATORIES GEMINI IMAGING SYSTEM 11/07/2001
K974455 ANALOGIC CORP. ANATOM 1000 (A MINUS, A-) 02/20/1998
K964890 ANALOGIC CORP. ANATOM 2000 03/06/1997
K052447 ANALOGIC CORP. SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600 09/21/2005
K172058 Analogic Corporation CT6485, CT12885 02/13/2018
K182147 Analogic Corporation CTXX85 09/07/2018
K201231 Analogic Corporation CTxx85 CT Scanner 02/02/2021
K213465 Arineta Ltd. CardioGraphe 12/02/2022
K161066 Arineta Ltd. SpotLight CT 08/10/2016
K960985 BIO-IMAGING RESEARCH, INC. SLS-CT 10/25/1996
K113732 BRAINLAB AG IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE) 05/07/2012
K230223 Bunkerhill, Inc iCAC Device 04/25/2023
K223261 Canon Medical Informatics, Inc. Open Rib 07/13/2023
K211828 Canon Medical Systems Corporation Aquilion Exceed LB 09/10/2021
K203042 Canon Medical Systems Corporation Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I 12/10/2020
K201836 Canon Medical Systems Corporation Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i 01/12/2021
K183046 Canon Medical Systems Corporation Aquilion ONE (TSX-305A/6) V8.9 with AiCE 06/12/2019
K192188 Canon Medical Systems Corporation Aquilion ONE (TSX-306A/3) V10.0 09/06/2019
K192828 Canon Medical Systems Corporation Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System 02/13/2020
K213504 Canon Medical Systems Corporation Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A 06/16/2022
K203225 Canon Medical Systems Corporation Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System 03/24/2021
K182901 Canon Medical Systems Corporation Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE 07/05/2019
K220986 Canon Medical Systems Corporation Aquilion Precision (TSX-304A/4) V10.10 with AiCE 09/12/2022
K223726 Canon Medical Systems Corporation Aquilion Precision (TSX-304A/4) V10.14 with AiCE 03/07/2023
K192832 Canon Medical Systems Corporation Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i 02/21/2020
K222819 Canon Medical Systems Corporation Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i 03/03/2023
K231281 Canon Medical Systems Corporation Aquilion Serve (TSX-307A/1) V1.3 09/19/2023
K181646 Canon Medical Systems Corporation Celesteion, PCA-9000A/3, V6.5 11/16/2018
K190505 Canon Medical Systems Corporation Low Dose Lung Screening Option 06/05/2019
K182223 Canon Medical Systems USA Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A 09/14/2018
K160723 CARESTREAM HEALTH, INC. OnSight 3D Extremity System 08/30/2016
K173478 Carestream Health, Inc. OnSight 3D Extremity System 01/19/2018
K080624 CAS INNOVATIONS AG NAVSTATIONIRAD EMT, VERSION 1.1 04/11/2008
K093787 CAS INNOVATIONS GMBH & CO. KG IGUIDE CAPPA 03/11/2010
K152473 CAScination AG CAS-One IR 01/20/2016
K183448 Cefla S.C. NewTom 5G XL 03/08/2019
K220664 CEFLA S.C. NewTom 7G 05/06/2022
K201898 Clear Guide Medical Clear Guide SCENERGY 07/31/2020
K153004 CLEAR GUIDE MEDICAL Clear Guide SCENERGY 02/12/2016
K171677 Clear Guide Medical Clear Guide SCENERGY 12/08/2017
K201188 Clear Guide Medical Clear Guide SCENERGY 09/30/2020
K011180 COLUMBIA SCIENTIFIC, INC. CT/MASTER, VERSION 1.0 06/27/2001
K191394 Covidien llc ILLUMISITE Platform 08/07/2019
K151376 Covidien LLC superDimension Navigation System 11/05/2015
K173244 Covidien LLC superDimension Navigation System V7.2 02/08/2018
K203187 CurveBeam, LLC HiRise 11/18/2020
K170789 CurveBeam, LLC In Reach 05/05/2017
K180727 CurveBeam, LLC LineUp 05/11/2018
K113548 CURVEBEAM, LLC PEDCAT 04/10/2012
K090991 E-WOO TECHNOLOGY COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO 10/09/2009
K070658 E-WOO TECHNOLOGY DENTAL DIGITAL PANORAMIC/3D IMAGING SYSTEM 04/05/2007
K081847 E-WOO TECHNOLOGY PICASSO MASTER, ECT AND MASTER 3D 08/21/2008
K011160 E-Z-EM, INC. E-Z EM PERCUPUMP 2001 CT INJECTOR 05/16/2001
K063029 E-Z-EM, INC. EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 11/02/2006
K071378 E-Z-EM, INC. MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES 06/13/2007
K151414 EDDA TECHNOLOGY IQQA Guide 11/20/2015
K970980 ELSCINT, INC. CARDIAC SCORING FOR CT SCANNERS 05/29/1997
K974344 ELSCINT, INC. CT SCOPE 06/03/1998
K961464 ELSCINT, INC. SELECT/SP 07/03/1996
K982060 ELSCINT, INC. VOLUMAX CT IMAGING SYSTEM 09/02/1998
K964583 ELSCINT, INC. XRT-7.0 01/17/1997
K970819 FERGUSON MEDICAL TARGOBEAM 07/14/1997
K191550 Fluidda Inc. Broncholab 03/04/2020
K173076 FMI Medical Systems Inc. CURA 16; ScintCare CT16 10/04/2018
K192590 FMI Medical Systems Inc. CURA 778 03/05/2020
K213829 FUJIFILM Healthcare Corporation SCENARIA View 05/23/2022
K153429 GE HANGWEI MEDICAL SYSTEM CO., LTD SmartView 3D Option 03/09/2016
K123596 GE HANGWEI MEDICAL SYSTEMS CO., LTD. OPTIMA CT520 02/08/2013
K192686 GE Hangwei Medical Systems Co.,Ltd. Revolution Maxima, Revolution Ace 10/24/2019
K192956 GE Hangwei Medical Systems, Co., Ltd. Auto Positioning 01/16/2020
K171013 GE Hangwei Medical Systems, Co., Ltd. Revolution ACT 06/05/2017
K060779 GE HEALTHCARE ADVANCE VESSEL ANALYSIS II 04/05/2006
K061625 GE HEALTHCARE AUTOBONE2 06/26/2006
K061370 GE HEALTHCARE CARDIQ FUSION 05/30/2006
K052839 GE HEALTHCARE CT PERFUSION 4 03/10/2006
K081105 GE HEALTHCARE GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0) 05/09/2008
K063324 GE HEALTHCARE PET VCAR 03/23/2007
K052855 GE HEALTHCARE STARSPEED SERIES CT SCANNER SYSTEMS 10/28/2005
K220961 GE Healthcare Japan Corporation Deep Learning Image Reconstruction 07/29/2022
K230807 GE Healthcare Japan Corporation Deep Learning Image Reconstruction 04/20/2023
K193170 GE Healthcare Japan Corporation Deep Learning Image Reconstruction 12/13/2019
K212067 GE Healthcare Japan Corporation Deep Learning Image Reconstruction 09/17/2021
K203169 GE Healthcare Japan Corporation Revolution Ascend 11/20/2020
K213938 GE Healthcare Japan Corporation Revolution Ascend 02/04/2022
K022794 GE IMATRON E-SPEED EBT SCANNER SYSTEM 10/11/2002
K974715 GE MEDICAL SYSTEMS ADVANTAGE 3D XR 07/06/1998
K031261 GE MEDICAL SYSTEMS CARD EP 05/06/2003
K020796 GE MEDICAL SYSTEMS CARD IQ ANALYSIS II 03/26/2002
K073138 GE MEDICAL SYSTEMS CARDIQ EXPRESS VERSION 2.0 02/26/2008
K013422 GE MEDICAL SYSTEMS CARDIQ FUNCTION 10/30/2001
K970606 GE MEDICAL SYSTEMS COMPUTED TOMOGRAPHY X-RAY SYSTEM 04/04/1997
K003408 GE MEDICAL SYSTEMS CT CORD IQ OPTION 1.0 11/17/2000
K961055 GE MEDICAL SYSTEMS CT PROSPEED CT/I 06/17/1996
K964746 GE MEDICAL SYSTEMS HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION 01/24/1997
K013561 GE MEDICAL SYSTEMS LIGHTSPEED 4.0 CT SCANNER SYSTEM 11/08/2001
K030420 GE MEDICAL SYSTEMS LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM 03/10/2003
K023332 GE MEDICAL SYSTEMS LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW 10/23/2002
K002978 GE MEDICAL SYSTEMS LIGTHSPEED 3.0 CT SCANNER SYSTEM 10/10/2000
K963896 GE MEDICAL SYSTEMS MOBILE CT PROSPEED FAMILY 12/18/1996
K012836 GE MEDICAL SYSTEMS MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM 09/07/2001
K022919 GE MEDICAL SYSTEMS SMART BREATH RESPIRATORY COMPENSATION OPTION 09/19/2002
K020929 GE MEDICAL SYSTEMS SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5 04/03/2002
K973168 GE MEDICAL SYSTEMS SMARTVIEW OPTIONS FOR HISPEED CT/I 11/21/1997
K031871 GE MEDICAL SYSTEMS EUROPE AUTOBONE 06/20/2003
K183204 GE Medical Systems SCS Bone VCAR (BVCAR) 04/08/2019
K073153 GE MEDICAL SYSTEMS SCS CARDIQ FUNCTION XPRESS 02/26/2008
K213725 GE Medical Systems SCS CardIQ Suite 03/11/2022
K120910 GE MEDICAL SYSTEMS SCS CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL 06/18/2012
K193289 GE Medical Systems SCS FastStroke, CT Perfusion 4D 11/12/2020
K180225 GE Medical Systems SCS GSI Viewer with GSI Fat Option 04/24/2018
K121827 GE MEDICAL SYSTEMS SCS GSI VIEWER WITH VUE OPTION 09/13/2012
K193281 GE Medical Systems SCS Hepatic VCAR 03/20/2020
K133649 GE MEDICAL SYSTEMS SCS HEPATIC VCAR 04/22/2014
K211180 GE Medical Systems SCS Liver Suite 05/02/2022
K223424 GE Medical Systems SCS Spine Auto Views 07/13/2023
K152584 GE MEDICAL SYSTEMS SCS Stroke VCAR 01/20/2016
K200626 GE Medical Systems SCS VesselIQ Xpress 02/16/2021
K972399 GE MEDICAL SYSTEMS, INC. ADVANTAGE WINDOWS VOLUME RENDERING OPTION 09/23/1997
K023943 GE MEDICAL SYSTEMS, INC. CT COLONOGRAPHY 05/06/2003
K012313 GE MEDICAL SYSTEMS, INC. CT COLONOGRAPHY/NAVIGATOR2 08/07/2001
K993791 GE MEDICAL SYSTEMS, INC. CT PERFUSION OPTION 11/24/1999
K993645 GE MEDICAL SYSTEMS, INC. CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM 12/21/1999
K010641 GE MEDICAL SYSTEMS, INC. GE CT-PET SYSTEM 03/30/2001
K091673 GE MEDICAL SYSTEMS, INC. GE LIGHTSPEED ACT FP16 06/24/2009
K082104 GE MEDICAL SYSTEMS, INC. GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM 09/02/2008
K021491 GE MEDICAL SYSTEMS, INC. HISPEED DUAL 05/22/2002
K991716 GE MEDICAL SYSTEMS, INC. HISPEED NX/I CT SCANNER SYSTEM 06/18/1999
K012385 GE MEDICAL SYSTEMS, INC. HISPEED X/I SMART GANTRY OPTION 08/10/2001
K000300 GE MEDICAL SYSTEMS, INC. LIGHTSPEED 2.0CT SCANNER SYSTEM 02/15/2000
K993792 GE MEDICAL SYSTEMS, INC. SMART VESSEL ANALYSIS (SMART VA) OPTION 11/24/1999
K163213 GE Medical Systems, L.L.C. Revolution CT 12/16/2016
K032915 GE MEDICAL SYSTEMS, LLC ADVANTAGE 4D OPTION 10/30/2003
K133640 GE MEDICAL SYSTEMS, LLC ASIR-V 03/25/2014
K201745 GE Medical Systems, LLC Deep Learning Image Reconstruction for Gemstone Spectral Imaging 12/10/2020
K132410 GE MEDICAL SYSTEMS, LLC DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W 01/17/2014
K120833 GE MEDICAL SYSTEMS, LLC DISCOVERY CT750 HD 06/12/2012
K093581 GE MEDICAL SYSTEMS, LLC DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS 04/19/2011
K082816 GE MEDICAL SYSTEMS, LLC GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM 10/08/2008
K082761 GE MEDICAL SYSTEMS, LLC GE LIGHTSPEED 7.2 CT SCANNER SYSTEM 10/08/2008
K060052 GE MEDICAL SYSTEMS, LLC GE LIGHTSPEED XTRA CT SCANNER SYSTEM 04/19/2006
K082960 GE MEDICAL SYSTEMS, LLC GE XTREME INJECTOR OPTION 10/17/2008
K052157 GE MEDICAL SYSTEMS, LLC INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ 08/25/2005
K033502 GE MEDICAL SYSTEMS, LLC LIGHTSPEED 6.0 CT SCANNER SYSTEM 11/20/2003
K040372 GE MEDICAL SYSTEMS, LLC LIGHTSPEED 7.0 CT SCANNER SYSTEM 03/01/2004
K061817 GE MEDICAL SYSTEMS, LLC LIGHTSPEED 7.1 CT SCANNER SYSTEM 07/12/2006
K151372 GE Medical Systems, LLC Low Dose CT Lung Cancer Screening Option for Qualified GE Systems 08/14/2015
K110227 GE MEDICAL SYSTEMS, LLC OPTIMA CT660 07/20/2011
K131576 GE MEDICAL SYSTEMS, LLC OPTIMA CT660 08/30/2013
K133705 GE MEDICAL SYSTEMS, LLC REVOLUTION CT 04/11/2014
K191777 GE Medical Systems, LLC Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition 07/26/2019
K223514 GE Medical Systems, LLC Spectral Bone Marrow 03/09/2023
K183202 GE Medical Systems, LLC. Deep Learning Image Reconstruction 04/12/2019
K213999 GE Medical Systems, LLC. Deep Learning Image Reconstruction 02/18/2022
K203617 GE Medical Systems, LLC. MaxFOV 2 03/02/2021
K183161 GE Medical Systems, LLC. SnapShot Freeze 2 02/13/2019
K213715 GE Medical Systems,LLC Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition 12/17/2021
K163281 GEf Medical Systems SCS FastStroke 01/26/2017
K013381 GENERAL ELECTRIC CO. ADVANCED LUNG ANALYSIS-1 10/26/2001
K982004 GENERAL ELECTRIC CO. CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS 08/18/1998
K010042 GENERAL ELECTRIC CO. CT PERFUSION 2 01/30/2001
K103489 GENERAL ELECTRIC CO. GE VEO RECONSTRUCTION OPTION 09/09/2011
K980169 GENERAL ELECTRIC CO. HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS 04/13/1998
K980176 GENERAL ELECTRIC CO. HISPEED QX/I CT SCANNER SYSTEM 04/13/1998
K041267 GENERAL ELECTRIC MEDICAL SYSTEMS CARDIQ ANALYSIS III 05/27/2004
K041521 GENERAL ELECTRIC MEDICAL SYSTEMS VOLUME VIEWER PLUS 06/22/2004
K220910 Hangzhou Deepwise & league of PHD Technology Co.,Ltd. Medical image processing software 08/11/2022
K180901 Hitachi Healthcare Americas Low Dose CT Lung Cancer Screening Option 05/16/2018
K190841 Hitachi Healthcare Americas SCENARIA View 09/13/2019
K200498 Hitachi Healthcare Americas SCENARIA View 07/17/2020
K183291 Hitachi Healthcare Americas Supria True64 Whole-Body X-Ray CT System 02/01/2019
K171738 Hitachi Healthcare Americas Corporation Supria True64 08/18/2017
K053148 HITACHI MEDICAL SYSTEMS AMERICA, INC. CXR16 02/17/2006
K071806 HITACHI MEDICAL SYSTEMS AMERICA, INC. ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM 08/28/2007
K091103 HITACHI MEDICAL SYSTEMS AMERICA, INC. GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS 06/15/2009
K113341 HITACHI MEDICAL SYSTEMS AMERICA, INC. GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM 05/03/2012
K040902 HITACHI MEDICAL SYSTEMS AMERICA, INC. HITACHI PRESTO 04/21/2004
K163528 Hitachi Medical Systems America, Inc. HITACHI Supria Whole-body X-ray CT System Phase 3 03/03/2017
K014240 HITACHI MEDICAL SYSTEMS AMERICA, INC. PRONTO 03/22/2002
K123509 HITACHI MEDICAL SYSTEMS AMERICA, INC. SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM 03/29/2013
K150595 HITACHI MEDICAL SYSTEMS AMERICA, INC. SCENARIA Phase 3 Whole-body X-ray CT System 10/30/2015
K101888 HITACHI MEDICAL SYSTEMS AMERICA, INC. SCENARIA WHOLE-BODY X-RAY CT SYSTEM 04/08/2011
K161748 HITACHI MEDICAL SYSTEMS AMERICA, INC. SUPRIA w/guideShot Option 08/17/2016
K150565 HITACHI MEDICAL SYSTEMS AMERICA, INC. Supria Whole-body X-ray CT System 09/30/2015
K003736 I.Z.I. CORP. MRI LINE MARKER 01/18/2001
K091529 ICAD, INC. ICAD VERALOOK CTC CAD SOFTWARE 08/04/2010
K162314 IMACTIS, SAS IMACTIS CT-Navigation system 04/24/2018
K040782 IMAGE ANALYSIS, INC. N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX 07/13/2004
K201092 Imaging Biometrics, LLC LSN 10/29/2020
K051980 IMAGING SCIENCES INTL., INC. DVT SCANNER 08/19/2005
K992740 IMATRON, INC. EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS 11/09/1999
K000359 IMATRON, INC. EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRO 03/17/2000
K972903 IMATRON, INC. IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS 11/04/1997
K972879 IMATRON, INC. ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION 10/15/1997
K141069 IMBIO LLC Lung Density Analysis 09/17/2014
K230112 Imbio, Inc. CAC Software 06/13/2023
K130224 IMRIS, INC. ICT 07/18/2013
K053046 IMTEC CORP. ILUMA ORTHOCAT/DENTALCAT 11/08/2005
K131433 ISYS MEDIZINTECHNIK GMBH ISYS 1 (U.S),ACCESSORY, NON-STERILE 03/11/2014
K203720 ISYS Medizintechnik GMBH MICROMATE 06/22/2021
K030450 J. MORITA USA, INC. 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH 05/06/2003
K052587 J. MORITA USA, INC. 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1 EXF 12/27/2005
K073695 J. MORITA USA, INC. 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17 04/09/2008
K093810 KGT INC. BF-NAVI 06/18/2010
K955583 KONICA MEDICAL CORP. VIFS 05/14/1996
K013999 LODOX SYSTEMS (PTY) LTD. LODOX, MODEL BASELINE 08/06/2002
K002005 MARCONI MEDICAL SYSTEMS, INC. BOLUSPRO ULTRA 09/22/2000
K012009 MARCONI MEDICAL SYSTEMS, INC. MX8000 IDT CT SYSTEM 09/13/2001
K163643 MASMEC SPA SIRIO H3 11/16/2017
K153331 MEDIC VISION IMAGING SOLUTIONS SafeCT-29 05/17/2016
K033102 MEDICSIGHT MEDIC COLON MODEL, RELEASE 1 11/05/2003
K032823 MEDICSIGHT MEDICHEART, MODEL RELEASE 1 11/10/2003
K033774 MEDIS MEDICAL IMAGING SYSTEMS, B.V. CT-MASS 03/02/2004
K062386 MEDIS MEDICAL IMAGING SYSTEMS, B.V. QANGIO CT 10/05/2006
K082458 MEDRAD, INC. P3T ABDOMEN 10/17/2008
K160126 Mobius Imaging AIRO Computed Tomography (CT) X-ray System 04/19/2016
K180393 Mobius Imaging, LLC AIRO Computed Tomography (CT) X-ray System 03/15/2018
K131431 MOBIUS IMAGING, LLC AIRO CT SYSTEM 09/26/2013
K213944 NanoxAI Ltd. HealthOST 04/22/2022
K160350 NEOCOIL, LLC ECG CT Gating Device 06/16/2016
K010813 NEORAD AS SIMPLICT 05/07/2001
K102677 NEUROLOGICA CORPORATION BODYTOM NL 4000 03/24/2011
K051765 NEUROLOGICA CORPORATION CERETOM, MODEL NL3000 07/14/2005
K142697 NEUROLOGICA CORPORATION NExCT 7 12/23/2014
K213649 NeuroLogica Corporation, BodyTom 64 04/29/2022
K171183 NeuroLogica Corporation, OmniTom 08/18/2017
K223447 NeuroLogica Corporation, a subsidiary of Samsung OmniTom Elite 06/01/2023
K170238 NeuroLogica Corporation, a Subsidiary of Samsung Electronics BodyTom Elite 06/14/2017
K172539 NeuroLogica Corporation, a Subsidiary of Samsung Electronics CereTom Elite 11/22/2017
K202526 NeuroLogica Corporation, a subsidiary of Samsung Electronics OmniTom Elite 12/23/2020
K211711 NeuroLogica Corporation, a subsidiary of Samsung Electronics OmniTom Elite 02/25/2022
K020913 NEUSOFT DIGITAL MEDICAL SYSTEMS CO., LTD. CT-C3000 SPIRAL CT SCANNER SYSTEM 04/03/2002
K041542 NEUSOFT DIGITAL MEDICAL SYSTEMS CO., LTD. CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS 06/17/2004
K133373 NEUSOFT MEDICAL SYSTEMS CO., LTD. CLEARVIEW 12/03/2014
K071308 NEUSOFT MEDICAL SYSTEMS CO., LTD. MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM 08/16/2007
K080540 NEUSOFT MEDICAL SYSTEMS CO., LTD. NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0 03/13/2008
K151383 NEUSOFT MEDICAL SYSTEMS CO., LTD. NeuViz 128 Multi-slice CT Scanner System 11/04/2015
K171198 Neusoft Medical Systems Co., Ltd. NeuViz 16 Essence Multi-slice CT Scanner System 12/07/2017
K090173 NEUSOFT MEDICAL SYSTEMS CO., LTD. NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM 02/05/2009
K092742 NEUSOFT MEDICAL SYSTEMS CO., LTD. NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM 09/22/2009
K121792 NEUSOFT MEDICAL SYSTEMS CO., LTD. NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM 11/16/2012
K062451 NEUSOFT MEDICAL SYSTEMS CO., LTD. NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM 09/28/2006
K171201 Neusoft Medical Systems Co., Ltd. NeuViz Prime Multi-slice CT Scanner System 09/13/2017
K072841 NEUSOFT MEDICAL SYSTEMS CO., LTD. NEUVIZ SPIRAL CT SCANNER SYSTEM 10/16/2007
K161285 NEUWAVE MEDICAL, INC. Ablation Confirmation 06/29/2016
K171022 NeuWave Medical, Inc. Ablation Confirmation 05/09/2017
K192427 NeuWave Medical, Inc. Ablation Confirmation 10/03/2019
K080581 OLYMPUS MEDICAL SYSTEMS CORPORATION VB IMAGE VIEWER 10/16/2008
K160611 P-CURE LTD. P-ARTIS 08/08/2016
K133901 PARITIC INC PARI-PATH SURGICAL NAVIGATION SYSTEM 06/27/2014
K132108 PERFINT HEALTHCARE PVT LTD MAXIO 05/19/2014
K121498 PHILIPS HEALTHCARE PERCUNAV 12/14/2012
K132087 PHILIPS HEALTHCARE PERCUNAV SYSTEM 07/24/2013
K131773 PHILIPS HEALTHCARE (CLEVELAND) BRILLIANCE ICT 09/24/2013
K123576 PHILIPS HEALTHCARE (CLEVELAND) IMR SOFTWARE APPLICATION 06/07/2013
K113483 PHILIPS HEALTHCARE (CLEVELAND) ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION 09/26/2012
K133674 PHILIPS HEALTHCARE (CLEVELAND) PHILIPS IQON SPECTRAL CT 11/21/2014
K223311 Philips Healthcare (Suzhou) Co., Ltd Philips CT 3500 12/22/2022
K191136 Philips Healthcare (Suzhou) Co., Ltd. Access CT 07/29/2019
K212441 Philips Healthcare (Suzhou) Co., Ltd. Philips Incisive CT 04/27/2022
K180015 Philips Healthcare (Suzhou) Co., Ltd. Philips Incisive CT 03/20/2018
K211168 Philips Healthcare (Suzhou) Co., Ltd. Philips Incisive CT on Trailer 11/22/2021
K203514 Philips Healthcare (Suzhou) Co., Ltd. Precise Position 06/17/2021
K132524 PHILIPS MEDICAL SYSTEMS CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION 06/13/2014
K133603 PHILIPS MEDICAL SYSTEMS PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION 09/25/2014
K171850 Philips Medical Systems (Cleveland) Inc. Philips CT Big Bore 11/09/2017
K163711 Philips Medical Systems (Cleveland), Inc. IQon Spectral CT 04/05/2017
K162838 Philips Medical Systems (Cleveland), Inc. Philips iCT CT System 04/07/2017
K160743 Philips Medical Systems (Cleveland), Inc. Philips Ingenuity CT 08/08/2016
K153444 PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. Philips Multislice CT System with Low Dose CT Lung Cancer 04/08/2016
K182716 Philips Medical Systems Nederland B.V. Brain Perfusion (BP) application 05/29/2019
K203020 Philips Medical Systems Nederland B.V. Spectral CT 02/26/2021
K212875 Philips Medical Systems Nederland B.V. Spectral CT on Rails 05/13/2022
K203216 Philips Medical Systems Nederland B.V. The Multimodality Advanced Vessel Analysis 11/25/2020
K210760 Philips Medical Systems Nederland, B.V. Precise Image 01/14/2022
K150665 PHILIPS MEDICAL SYSTEMS NETHRLANDS BV Philips Spectral CT Applications 08/07/2015
K012238 PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. DOSERIGHT 10/01/2001
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