FDA 510(k) Applications for Medical Device Product Code "JAK"
(System, X-Ray, Tomography, Computed)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K232392 | 4DMedical Limited | CT Lung Ventilation Analysis Software (CT:V) | 11/16/2023 |
| 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 |
| K231631 | Aidoc Medical, Ltd. | BriefCase-Quantification | 11/28/2023 |
| 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 |
| K250650 | Arineta Ltd. | SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option | 04/15/2025 |
| K161066 | Arineta Ltd. | SpotLight CT | 08/10/2016 |
| K230370 | Arineta Ltd. | SpotLight/SpotLight Duo (with DLIR option) | 10/13/2023 |
| K241200 | Arineta Ltd. | SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option | 01/13/2025 |
| 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 |
| K242411 | Brainomix Limited | Brainomix 360 e-Lung | 02/19/2025 |
| K233875 | Brainomix Limited | Brainomix 360 e-Lung | 05/13/2024 |
| K243229 | BunkerHill Health | Bunkerhill AVC | 01/27/2025 |
| K240369 | BunkerHill Health | CAC (gated) Algorithm | 09/27/2024 |
| K230223 | Bunkerhill, Inc | iCAC Device | 04/25/2023 |
| K223261 | Canon Medical Informatics, Inc. | Open Rib | 07/13/2023 |
| K243240 | Canon Medical Informatics, Inc. | Vitrea CT VScore | 04/10/2025 |
| 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 |
| K232835 | Canon Medical Systems Corporation | Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System | 04/02/2024 |
| K242403 | Canon Medical Systems Corporation | Aquilion ONE (TSX-308A/3) V1.5 | 12/23/2024 |
| 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 |
| K233334 | Canon Medical Systems Corporation | Aquilion Serve SP (TSX-307B/1) V1.3 | 12/06/2023 |
| K181646 | Canon Medical Systems Corporation | Celesteion, PCA-9000A/3, V6.5 | 11/16/2018 |
| K243398 | Canon Medical Systems Corporation | CT Scanner TSX-501R/1 V11.1 | 06/20/2025 |
| 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 |
| K232022 | Cascination AG | CAS-One IR | 03/13/2024 |
| 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 |
| K234030 | Clear Guide Medical | Clear Guide SCENERGY | 01/17/2024 |
| 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 |
| K241713 | CurveBeam LLC | HiRise (1040-230) | 07/12/2024 |
| 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 |
| K250370 | FUJIFILM Corporation | SCENARIA View Phase 5.0 | 05/20/2025 |
| K233583 | FUJIFILM Healthcare Americas Corporation | FCT iSTREAM Phase 1 | 04/26/2024 |
| K231574 | Fujifilm Healthcare Americas Corporation | Scenaria View 4.2 | 10/12/2023 |
| 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 |
| K233749 | GE Hangwei Medical Systems Co., Ltd. | Revolution Ascend Sliding | 02/22/2024 |
| 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 |
| K233698 | GE Healthcare Japan Corporation | True Enhance DL | 04/11/2024 |
| 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 |
| K233731 | GE Medical Systems SCS | CardIQ Suite | 08/01/2024 |
| K213725 | GE Medical Systems SCS | CardIQ Suite | 03/11/2022 |
| K243672 | GE Medical Systems SCS | CardIQ Suite | 06/18/2025 |
| 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 |
| K233750 | GE Medical Systems, LLC. | ECG-less Cardiac | 04/02/2024 |
| 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 |
| K230130 | ISYS Medizintechnik GMBH | MicromateÖ Navi+ | 10/10/2023 |
| 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 |
| K250970 | Leo Cancer Care | Marie | 07/25/2025 |
| 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 |
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