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

FDA 510(k) Number Applicant Device Name Decision Date
K012106 ACCUIMAGE DIAGNOSTICS CORP. ACCUIMAGE SMARTGATE UPGRADE 09/25/2001
K024149 ACCUIMAGE DIAGNOSTICS CORP. PRIMELUNG 02/21/2003
K120300 ACTIVIEWS LTD CT-GUIDE NEEDLE GUIDANCE SYSTEM 04/13/2012
K110812 ACTIVIEWS LTD CT-GUIDE NEEDLE GUIDANCE SYSTEM 06/21/2011
K113063 ACTIVIEWS LTD CT-GUIDE NEEDLE GUIDANCE SYSTEM 11/10/2011
K811358 ACUMEDIA MANUFACTURERS, INC. DEHYDRATED BILE 05/29/1981
K013521 ADAC LABORATORIES GEMINI IMAGING SYSTEM 11/07/2001
K760201 AMERICAN SCIENCE AND ENGINEERING, INC. X-RAY SCANNER, COMPUTERIZED TOMOGRAPHIC 10/05/1976
K974455 ANALOGIC CORP. ANATOM 1000 (A MINUS, A-) 02/20/1998
K964890 ANALOGIC CORP. ANATOM 2000 03/06/1997
K944131 ANALOGIC CORP. ANATOM 2000 01/25/1995
K052447 ANALOGIC CORP. SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600 09/21/2005
K172058 Analogic Corporation CT6485, CT12885 02/13/2018
K161066 Arineta Ltd. SpotLight CT 08/10/2016
K760882 ARNOLD & PORTER FOR G.E. CO. GE CT/T MODEL NO. B7800 A 11/19/1976
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
K173478 Carestream Health, Inc. OnSight 3D Extremity System 01/19/2018
K160723 CARESTREAM HEALTH, INC. OnSight 3D Extremity System 08/30/2016
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
K781040 CGR MEDICAL CORP. CT SCANNER ND 8000 07/18/1978
K811723 CGR MEDICAL CORP. WHOLE BODY SCANNER 07/20/1981
K153004 CLEAR GUIDE MEDICAL Clear Guide SCENERGY 02/12/2016
K171677 Clear Guide Medical Clear Guide SCENERGY 12/08/2017
K885322 COLUMBIA SCIENTIFIC, INC. 3D/DENTAL 02/09/1989
K870513 COLUMBIA SCIENTIFIC, INC. CSI/3D 05/08/1987
K011180 COLUMBIA SCIENTIFIC, INC. CT/MASTER, VERSION 1.0 06/27/2001
K924810 COLUMBIA SCIENTIFIC, INC. SIM/PLANT 01/15/1993
K923109 COOK, INC. ADULT CHIN STRAP FOR CT TABLES 09/23/1992
K923111 COOK, INC. ARM EXTENDER FOR CT TABLES 09/23/1992
K923114 COOK, INC. HEAD RESTRAINT FOR CT TABLES 09/23/1992
K923106 COOK, INC. SCAN BAND 09/11/1992
K923110 COOK, INC. SCAN BAND 09/23/1992
K923108 COOK, INC. WRIST RESTRAINT FOR GE9800 C.T. TABLES 09/23/1992
K151376 Covidien LLC superDimension Navigation System 11/05/2015
K173244 Covidien LLC superDimension Navigation System V7.2 02/08/2018
K170789 CurveBeam, LLC In Reach 05/05/2017
K180727 CurveBeam, LLC LineUp 05/11/2018
K113548 CURVEBEAM, LLC PEDCAT 04/10/2012
K884268 DYNAMIC DIGITAL DISPLAYS, INC. VOXELSCOPE(TM) 12/20/1988
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
K912454 EASTMAN KODAK COMPANY KODAK EKTASCAN XLP PRELIMINARY DV2000 INTERFACE 09/27/1991
K151414 EDDA TECHNOLOGY IQQA Guide 11/20/2015
K932508 ELSCINT, INC. ANGIOCT OPTION FOR CT-TWIN, HELICAT & OMNIVIEW 07/29/1994
K970980 ELSCINT, INC. CARDIAC SCORING FOR CT SCANNERS 05/29/1997
K974344 ELSCINT, INC. CT SCOPE 06/03/1998
K894542 ELSCINT, INC. ELSCINT'S EXEL 2400E CT SCANNER 09/07/1989
K915738 ELSCINT, INC. EXCEL CT TWIN 07/21/1992
K884668 ELSCINT, INC. EXEL 1002 CT SCANNER 12/30/1988
K884670 ELSCINT, INC. EXEL 1800 AND 1800E CT SCANNER 01/18/1989
K884669 ELSCINT, INC. EXEL 2002 & 2002FS CT SCANNER 12/30/1988
K884671 ELSCINT, INC. EXEL 2400 AND 2400 ELITE CT SCANNERS 01/18/1989
K884667 ELSCINT, INC. EXEL 905 SERIES CT SCANNER 12/30/1988
K930090 ELSCINT, INC. HELICAT 03/19/1993
K945512 ELSCINT, INC. HRSW OPTION FOR CT TWIN FLASH 03/14/1995
K900170 ELSCINT, INC. MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U 07/25/1990
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
K780930 EMI MEDICAL, INC. 5543 INDEPENDENT VIEWING SYSTEM 06/14/1978
K780737 EMI MEDICAL, INC. CT BLANKETS (BOLUS MATERIAL) 06/02/1978
K780928 EMI MEDICAL, INC. CT5137 HIGH RESOLUTION OPTION 06/14/1978
K771978 EMI MEDICAL, INC. CTR 100L 11/23/1977
K771811 EMI MEDICAL, INC. EMI CTR 100 10/19/1977
K781936 EMI MEDICAL, INC. SCANNER-EMI 7020 AND 7020R 12/04/1978
K772125 EMI MEDICAL, INC. TOMOGRAPHIC SCANNER, COMPUTERIZED 11/21/1977
K970819 FERGUSON MEDICAL TARGOBEAM 07/14/1997
K760808 G.D. SEARLE AND CO. PHO. TRAX MODEL 4000 WHOLE BODY SCAN. 11/05/1976
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
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
K022794 GE IMATRON E-SPEED EBT SCANNER SYSTEM 10/11/2002
K974715 GE MEDICAL SYSTEMS ADVANTAGE 3D XR 07/06/1998
K923077 GE MEDICAL SYSTEMS ADVANTAGE WINDOWS 3D OPTION AND DENTASCAN OPTION 02/02/1993
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
K894269 GE MEDICAL SYSTEMS CT HILIGHT ADVANTAGE 09/01/1989
K904971 GE MEDICAL SYSTEMS CT HILIGHT ADVANTAGE II 01/14/1991
K961055 GE MEDICAL SYSTEMS CT PROSPEED CT/I 06/17/1996
K944013 GE MEDICAL SYSTEMS CT PROSPEED FAMILY 02/07/1995
K911387 GE MEDICAL SYSTEMS CT SYTEC 4000 05/09/1991
K921192 GE MEDICAL SYSTEMS CT SYTEC 6000 COMPUTED TOMOGRAPHY SYSTEM 10/20/1992
K940606 GE MEDICAL SYSTEMS HISPEED ADVANTAGE II 08/23/1994
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
K073153 GE MEDICAL SYSTEMS SCS CARDIQ FUNCTION XPRESS 02/26/2008
K120910 GE MEDICAL SYSTEMS SCS CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL 06/18/2012
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
K133649 GE MEDICAL SYSTEMS SCS HEPATIC VCAR 04/22/2014
K152584 GE MEDICAL SYSTEMS SCS Stroke VCAR 01/20/2016
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
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
K131576 GE MEDICAL SYSTEMS, LLC OPTIMA CT660 08/30/2013
K110227 GE MEDICAL SYSTEMS, LLC OPTIMA CT660 07/20/2011
K133705 GE MEDICAL SYSTEMS, LLC REVOLUTION CT 04/11/2014
K163281 GEf Medical Systems SCS FastStroke 01/26/2017
K013381 GENERAL ELECTRIC CO. ADVANCED LUNG ANALYSIS-1 10/26/2001
K820688 GENERAL ELECTRIC CO. ARRANGE TM 03/31/1982
K903763 GENERAL ELECTRIC CO. COMPUTED TOMOGRAPHY X-RAY SYSTEM 11/02/1990
K843927 GENERAL ELECTRIC CO. CT 9000 12/17/1984
K841997 GENERAL ELECTRIC CO. CT 9800 09/04/1984
K982004 GENERAL ELECTRIC CO. CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS 08/18/1998
K882581 GENERAL ELECTRIC CO. CT MAX 640 #B7940 JA/JE 08/15/1988
K862317 GENERAL ELECTRIC CO. CT MAX, CATALOG NO. B7940 HA 10/07/1986
K872526 GENERAL ELECTRIC CO. CT PACE CATALOG NUMBER B7950A 09/23/1987
K010042 GENERAL ELECTRIC CO. CT PERFUSION 2 01/30/2001
K893820 GENERAL ELECTRIC CO. CT SYTEC 3000 08/07/1989
K913485 GENERAL ELECTRIC CO. CT SYTEC 8000 01/23/1992
K760688 GENERAL ELECTRIC CO. CT/N-II SCANNER SYSTEM 10/05/1976
K812509 GENERAL ELECTRIC CO. CT/T 8800 10/13/1981
K812241 GENERAL ELECTRIC CO. CT/T 9800 09/09/1981
K811227 GENERAL ELECTRIC CO. CT/T DATALINK-B7875 AA/B7875 AB 07/10/1981
K780480 GENERAL ELECTRIC CO. CT/T INDEPENDENT DIAGNOSTIC CENTER 04/18/1978
K772317 GENERAL ELECTRIC CO. CT/T SYSTEM MODEL B7800A 01/11/1978
K871859 GENERAL ELECTRIC CO. CT9800 QUICK 3D #B7919DA 08/12/1987
K781431 GENERAL ELECTRIC CO. ELECTRIC CT/T OPERATOR DISPLAY CONSOLE 09/07/1978
K802045 GENERAL ELECTRIC CO. G.E. SCAN CAPABILITY CAT.#B7815F 10/23/1980
K780326 GENERAL ELECTRIC CO. GE CT/T 8800 SYSTEM 03/14/1978
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
K852865 GENERAL ELECTRIC CO. OPTICAL DISC UNIT 10/10/1985
K790134 GENERAL ELECTRIC CO. RADIOTHERAPY TREATMENT 02/21/1979
K790942 GENERAL ELECTRIC CO. RADVIEW IMAGER SYSTEM 06/27/1979
K803181 GENERAL ELECTRIC CO. SCANNER, COMPUTERIZED TOMOGRAPHIC 01/28/1981
K861708 GENERAL ELECTRIC CO. SOLID STATE DETECTOR COMPUTERIZED TOMOGRAPHIC 08/29/1986
K914305 GENERAL ELECTRIC CO. SYTEC DENTASCAN 02/27/1992
K041267 GENERAL ELECTRIC MEDICAL SYSTEMS CARDIQ ANALYSIS III 05/27/2004
K041521 GENERAL ELECTRIC MEDICAL SYSTEMS VOLUME VIEWER PLUS 06/22/2004
K934832 HERAEUS KULZER, INC. IMPAX 3000 12/14/1993
K180901 Hitachi Healthcare Americas Low Dose CT Lung Cancer Screening Option 05/16/2018
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
K872150 I.S.G. TECHNOLOGIES, INC. I.S.G. 3DMV WORKSTATION 08/12/1987
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
K891931 IMAGE ANALYSIS, INC. QCT-LUNG NODULE (TM) ANALYSIS PACKAGE 05/18/1989
K844926 IMAGING ACCESSORIES, INC. HEAD-SPINE STABILIZER HSS-1 04/16/1985
K051980 IMAGING SCIENCES INTL., INC. DVT SCANNER 08/19/2005
K913352 IMATRON, INC. C-150 ULTRAFAST CT SCANNER 11/29/1991
K864046 IMATRON, INC. C-IOO MOBILE CINE CT UNIT 11/10/1986
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
K872615 IMATRON, INC. IMATRON C-100 ULTRAFAST CT SCANNER 09/23/1987
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
K130224 IMRIS, INC. ICT 07/18/2013
K053046 IMTEC CORP. ILUMA ORTHOCAT/DENTALCAT 11/08/2005
K813162 INTERAD SYSTEMS, INC. INTERAD WHOLE BODY CT SCANNER 12/14/1981
K930765 INTERNATIONAL IMAGING ELECTRONICS ULTRA COMPACT VIDEO IMAGER 09/13/1993
K131433 ISYS MEDIZINTECHNIK GMBH ISYS 1 (U.S),ACCESSORY, NON-STERILE 03/11/2014
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
K935454 LUNAR CORP. DPX TISSUE QUANTIFICATION OUTPUT 10/19/1995
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
K911764 MEDICAL IMAGING TECHNOLOGIES, INC. IMAC2000 09/23/1991
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
K944983 MEDRAD, INC. MEDRAD COUNTERPOISE SYSTEM 11/29/1994
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
K882906 MPDI, INC. DENTASCAN 08/19/1988
K942040 MRX CORP. MRX-280 07/05/1994
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
K171183 NeuroLogica Corporation, OmniTom 08/18/2017
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
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
K092742 NEUSOFT MEDICAL SYSTEMS CO., LTD. NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM 09/22/2009
K090173 NEUSOFT MEDICAL SYSTEMS CO., LTD. NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM 02/05/2009
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
K150313 NEUWAVE MEDICAL INC. Ablation Confirmation 07/09/2015
K161285 NEUWAVE MEDICAL, INC. Ablation Confirmation 06/29/2016
K171022 NeuWave Medical, Inc. Ablation Confirmation 05/09/2017
K113725 O.N. DIAGNOSTICS VIRTUOST 09/13/2012
K792603 OHIO NUCLEAR, INC. COMPUTED TOMOGRAPHY X-RAY SCANNER 01/28/1980
K771082 OHIO NUCLEAR, INC. DELTASCAN 2000 SERIES 06/24/1977
K791195 OHIO NUCLEAR, INC. DELTASCAN COMPUTER TOMOGRAPHY X-RAY SCAN 07/30/1979
K772305 OHIO NUCLEAR, INC. RAD. THERAPY PLANNING SUP. SYS. 01/09/1978
K780115 OHIO NUCLEAR, INC. SCANNERS, TOMOGRAPHIC, COMPUTED 01/30/1978
K932848 OLDELFT CORP. OF AMERICA SIMULIX-MC CT EXTENSION 03/22/1994
K080581 OLYMPUS MEDICAL SYSTEMS CORPORATION VB IMAGE VIEWER 10/16/2008
K812393 OMNIMEDICAL 4001 CT SCANNER 10/13/1981
K802206 OMNIMEDICAL OMNI SCANNER CT 6000 10/23/1980
K812400 OMNIMEDICAL OMNIMEDICAL QUAD I 10/02/1981
K771990 OMNIMEDICAL SERVICES, INC. OMNIMEDICAL 400L 11/30/1977
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