FDA 510(k) Applications for Medical Device Product Code "LLZ"
(System, Image Processing, Radiological)

FDA 510(k) Number Applicant Device Name Decision Date
K121075 3D IMAGING PARTNERS INC. NERVEVISION SOFTWARE SYSTEMS 07/26/2012
K180629 3D Industrial Imaging Co., Ltd DentiqGuide 07/19/2018
K160666 3D INDUSTRIAL IMAGING CO.,LTD. Dentiq3D 10/05/2016
K021913 3D MED CO., LTD. CALSCOR SOFTWARE 09/06/2002
K012290 3D MED CO., LTD. RAPIDIA 09/28/2001
K161841 3D SYSTEMS, INC. D2P 01/09/2017
K151687 3DISC AMERICAS QuantorView 08/03/2015
K013841 3DSHARP, INC. 3DFIS, MODEL IES-FL-101 01/17/2002
K153705 3DSYSTEMS, SIMBIONIX PRODUCTS PROcedure Rehearsal Studio 09/02/2016
K094064 3M IMTEC ILUMA VISION MODEL VERSION 2.2 04/30/2010
K043097 3MENSIO MEDICAL IMAGING BV 3VISEON 11/19/2004
K072653 3MENSIO MEDICAL IMAGING BV 3VISEON/SURGERY 01/24/2008
K141570 3SHAPE MEDICAL A/S IMPLANT STUDIO 10/31/2014
K152078 3Shape Medical A/S Implant Studio 2015 12/04/2015
K050862 3TP LLC 3TP WORKSPACE 07/25/2005
K161559 4QIMAGING, LLC DBA QMETRICS Kuvia3D 06/23/2016
K973148 A. STEIN - REGULATORY AFFAIRS CONSULTING MACOM 11/20/1997
K963610 A.L.I. TECHNOLOGIES, INC. AKI COMPACS DATA COMPRESION MODULE FOR DIAGNOSTIC IMAGES 11/27/1996
K003762 A.L.I. TECHNOLOGIES, INC. ALI 3D TOOL MODULE FOR MEDICAL IMAGES 02/28/2001
K072637 A2D IMAGING LLC DIVO 12/11/2007
K003746 ABLE SOFTWARE CORP. 3D-DOCTOR 03/13/2001
K990241 ACCUIMAGE DIAGNOSTICS CORP. ACCUIMAGE, ACCUVIEW DIAGNOSTIC IMAGING, WORKSTATION W/ACCUSCORE, ACCUANALYZE, ACCUSCOPE, ACCUSHADE, ACCUVRT, AND ACCUMIP 09/23/1999
K110765 ACES GMBH FXA (TM) 11/04/2011
K150069 Acuitas Medical Ltd. Fine Structure Analysis(fineSA) 05/22/2015
K022896 ACUSON CORP. CSV12 SOFTWARE VIEWER 10/03/2002
K023772 ACUSON CORP. KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM 11/22/2002
K843708 ADAC LABORATORIES ADAC DPS-4070 DIGITAL RADIOGRAPHY SYS 04/16/1985
K844298 ADAC LABORATORIES ADAC MODEL DPS-3300M DIGITAL PROCESSING SYSTEM 03/01/1985
K881017 ADAC LABORATORIES DPS-33,000 WITH CENTOR OPTION 08/11/1988
K844783 ADAC LABORATORIES DPS-3300 MICRO NUCLEAR MEDICINE IMAGING COMPUTER 02/01/1985
K844784 ADAC LABORATORIES DPS-33000 NUCLEAR MEDICINE IMAGING COMPUTER 02/01/1985
K872455 ADAC LABORATORIES DPS-4100 PLUS DIGITAL RADIOGRAPHY SYSTEM 09/01/1987
K040142 ADAC LABORATORIES ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE 02/06/2004
K061029 ADAC LABORATORIES JETSTREAM WORKSPACE 05/01/2006
K915305 ADAC LABORATORIES OPTION U1 FOR THE DPS-PLUS SYSTEM 02/26/1992
K974474 ADAC LABORATORIES PEGASYS INTOUCH 02/24/1998
K993946 ADAC LABORATORIES PEGASYS ULTRA 03/09/2000
K021669 ADAC LABORATORIES PHYSICIAN'S DESKTOP REVIEW 06/05/2002
K022428 ADAC LABORATORIES QUANTITATIVE BLOOD POOL SPECT (QBS) 08/06/2002
K882205 ADAC LABORATORIES VIEWPOINT 08/11/1988
K062059 ADVANCED IMAGE ENHANCEMENT AIE REGION OF INTEREST IMAGE ENHANCEMENT 09/06/2006
K062878 ADVANCED IMAGING SOLUTIONS, LLC EZPACS, VERSION 3.0 06/27/2007
K002144 ADVANCED TECHNOLOGY LABORATORIES, INC. MEDLINK DIAGNOSTIC OFFLINE WORKSTATION 09/28/2000
K021966 ADVANCED TECHNOLOGY LABORATORIES, INC. Q LAB SOFTWARE 07/02/2002
K861279 ADVANTAGE MEDICAL SYSTEMS, INC. "FLUORO PLUS" 06/16/1986
K012093 AETMED, S.P.A. AETMED IMAGE PROCESSING SOFTWARE 09/21/2001
K010571 AGFA CORP. ADC QS/IPD WORKSTATION 03/28/2001
K040555 AGFA CORP. IMPAX CLIENT EMBRACE 05/26/2004
K022292 AGFA CORP. IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO 09/12/2002
K050751 AGFA CORP. IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X 04/21/2005
K040344 AGFA CORP. IMPAX OT3000 ORTHOPEDIC WORKSTATION 05/12/2004
K053458 AGFA CORP. WEB1000 12/22/2005
K071297 AGFA HEALTHCARE CORP. IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION) 06/22/2007
K071972 AGFA HEALTHCARE CORP. ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS 07/30/2007
K081976 AGFA HEALTHCARE CORPORATION IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION 07/28/2008
K073271 AGFA HEALTHCARE CORPORATION ORTHOGON 12/05/2007
K080013 AGFA HEALTHCARE CORPORATION REGISTRATION AND FUSION 01/17/2008
K170434 Agfa HealthCare N.V. Enterprise Imaging XERO Viewer 8.1 07/03/2017
K143397 Agfa HealthCare N.V. ICIS View 06/01/2015
K142316 AGFA HEALTHCARE N.V. IMPAX Agility 01/06/2015
K111945 AGFA HEALTHCARE N.V. IMPAX NEXT GENERATION 08/05/2011
K111638 AGFA HEALTHCARE N.V. IMPAX VOLUME VIEWING 06/24/2011
K133135 AGFA HEALTHCARE N.V. IMPAX VOLUME VIEWING 3.0 03/07/2014
K161061 AGFA HEALTHCARE N.V. IMPAX Volume Viewing 4.0 06/22/2016
K173444 AIQ Solutions, Inc. Quantitative Total Extensible Imaging (QTxI) 07/23/2018
K021934 AISOFTW@RE MEDICAL, S.P.A. MODIFICATION TO MEDSTATION 08/12/2002
K092427 ALBERT DAVYDOV DDS PC PROFESSIONAL SPINAL GUIDES PACS (PACS MEDICAL IMAGING DISPLAY WORKSTATION) 03/16/2010
K161625 ALGOMEDICA PixelShine 09/19/2016
K033013 ALGOTEC SYSTEMS, LTD. MDIFICATION TO MEDIPRIME 11/25/2003
K002894 ALGOTEC SYSTEMS, LTD. MEDIPRIME 12/05/2000
K023936 ALGOTEC SYSTEMS, LTD. MODIFICATION TO MEDIPRIME 12/20/2002
K954678 ALGOTEC SYSTEMS, LTD. PRO VISION 01/05/1996
K980648 ALGOTEC SYSTEMS, LTD. PRO VISION 07/20/1998
K072258 ALMEN LABORATORIES, INC. BI-RADS COMPANION 05/16/2008
K081843 ALOKA CO., LTD. ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1 07/15/2008
K081304 ALZ, INC. ALZ WEB PACS, VERSION 1.0 06/11/2008
K180867 AmCad BioMed Corporation AmCAD-UO 12/28/2018
K162574 AmCad BioMed Corporation AmCAD-US 05/30/2017
K180006 AmCad BioMed Corporation AmCAD-UT Detection 2.2 08/31/2018
K170069 AmCad BioMed Corporation AmCAD-UV 04/26/2017
K101654 AMERICAN DENTAL PARTNERS, INC IMPROVIS IMAGING SYSTEM 11/10/2010
K021072 AMERICAN MEDICAL RESOURCES, LTD. (AMR) FILMSAVER, NT VERSION 5.03 06/06/2002
K052537 AMERICAN MEDICAL SALES, INC. CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0 11/16/2005
K080290 AMERICAN RADIOLOGIST NETWORK, INC. XVIEWNET 02/22/2008
K022970 AMICAS, INC. AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0 11/22/2002
K082144 AMICAS, INC. AMICAS PACS, VERSION 6.0 09/05/2008
K062477 AMICAS, INC. AMICAS VISION SERIES PACS, MODEL 4.3 10/27/2006
K073526 AMICAS, INC. AMICAS VISION SERIES PACS, MODEL 5.5 03/12/2008
K040399 AMID QONTRAST 03/29/2004
K110108 AMPRONIX, INC. MODALIXX 03/16/2011
K980168 ANALOGIC CORP. COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE 04/02/1998
K991626 ANALOGIC CORP. WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION 07/02/1999
K150976 ANATOMAGE INC. Collage 06/04/2015
K181926 Anatomage Inc. InVivo Web Viewer 09/21/2018
K140093 ANATOMAGE INC. TABLE 03/07/2014
K161270 ANATOMAGE, INC CephSimulation 01/04/2017
K123519 ANATOMAGE, INC INVIVO DENTAL 02/01/2013
K070803 ANATOMAGE, INC INVIVODENTAL 04/06/2007
K892869 ANDROS ANALYZERS, INC. ANGIOTEC ZX DIGITAL IMAGE PROCESSOR 05/26/1989
K043350 APOLLO MEDICAL IMAGING TECHNOLOGY PTY LTD. MISTAR, MODEL V3.2 12/15/2004
K982862 APPLICARE MEDICAL IMAGING, B.V. RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE 10/21/1998
K983111 APTERYX, INC. XRAY VISION 11/16/1998
K132342 APTERYX, INC. XVWEB 12/20/2013
K182815 Apteryx, Inc. XVWeb 3D 11/30/2018
K973653 AREEDA ASSOC., LTD. SEEMOR - DISPLAY & PROCESSING PROGRAM EXECUTING ON PERSONAL COMPUTER SYSTEM 12/12/1997
K041782 AREEDA ASSOC., LTD. SEEMOR 5.0 IMAGE DISPLAY PROGRAM 08/16/2004
K993283 ARNOLD & RICHTER CINE TECHNIK OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C 12/29/1999
K163253 ARTERYS INC. Arterys Cardio DL 01/05/2017
K182034 Arterys Inc. Arterys MICA 10/17/2018
K173542 Arterys Inc. Arterys Oncology DL 01/25/2018
K162513 ARTERYS INC. Arterys Software v2.0 10/28/2016
K171544 Arterys Inc. Arterys Viewer 07/18/2017
K142944 Arthromeda, Inc ArthroPlan Digital Templating Software 12/16/2014
K051639 AS SOFTWARE, INC. AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEM 08/02/2005
K081752 ASHVA TECHNOLOGIES, PVT. LTD EDGE PACS 08/06/2008
K071602 ASHVA TECHNOLOGIES, PVT. LTD IMAGIC V2.0 07/23/2007
K091631 ASPYRA, INC. ACCESSNET, ACCESSMED, ACCESSRAD, MEDVIEW 03/18/2010
K940664 ASTRO OFFICE PRODUCTS, INC. PAPER FILM 11/15/1994
K122022 ATHEROPOINT LLC ATHEROEDGE 09/26/2012
K900851 ATOMIC PRODUCTS CORP. DIGITAL IMAGE ENHANCEMENT SYSTEM 05/11/1990
K962589 AURORA TECHNOLOGY, INC. AURORA DIAGNOSTIC WORKSTATION 09/20/1996
K141556 AVREO, INC. AVREO INTERWORKS SYSTEM 07/02/2014
K070755 AVREO, INC. INTERWORKS 05/08/2007
K103679 AXIS HEALTH CARE, LLC AXIS PACS, HMS PACS 03/03/2011
K141536 AXON MEDICAL TECHNOLOGIES CORP. VIEWING CLIENT MOBILE 03/06/2015
K122260 AYCAN DIGITALSYSTEME GMBH AYCAN MOBILE 09/12/2012
K063470 AYCAN DIGITALSYSTEME GMBH AYCAN WORKSTATION OSIRIX 01/05/2007
K103546 AYCAN DIGITALSYSTEME GMBH AYCAN WORKSTATION OSIRIX PRO 03/17/2011
K133521 AZE, LTD. AZE PHOENIX SOFTWARE 04/11/2014
K060453 AZE, LTD. AZE VIRTUALPLACE 03/09/2006
K102534 AZE, LTD. AZE VIRTUALPLACE-MR FLOW ANALYSIS SOFTWARE 05/24/2011
K051392 B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. BTI-SCAN, VERSION 4.0 06/29/2005
K131246 BARCO N.V. CORONIS 3MP 05/24/2013
K130103 BARCO N.V. CORONIS FUSION 6MP 02/08/2013
K133663 BARCO N.V. NIO COLOR 2MP 03/25/2014
K090603 BARCO NV BARCO 5MP MAMMO, MODEL MDMG-5221 04/22/2009
K103792 BARCO NV BARCO MAMMO TOMOSYNTHESIS 03/04/2011
K982690 BARCO NV BARCO MEDICAL DISPLAY CONFORMITY AND CONSISTENCY SOFTWARE 10/06/1998
K022773 BARCO NV BARCO MEDIS 2MP1NT MEDICAL DIAGNOSTIC DISPLAY SYSTEM 12/13/2002
K023533 BARCO NV BARCO MEDIS 5MP2 AURA 01/17/2003
K000293 BARCO NV BARCO MGD 221 2 MEGAPIXEL DIAGNOSTIC DISPLAY 03/29/2000
K000292 BARCO NV BARCO MWD 321 PLUS MEDICAL WORKSTATION DISPLAY 03/29/2000
K000015 BARCO NV BARCOMED 2MP2 02/04/2000
K000014 BARCO NV BARCOMED 5MP1H 03/14/2000
K000016 BARCO NV BARCOMED 5MP2 03/14/2000
K040365 BARCO NV COLOR CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM 04/28/2004
K023341 BARCO NV CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM 12/23/2002
K023340 BARCO NV CORONIS 1MP MEDICAL FLAT PANEL DISPLAY SYSTEM 12/23/2002
K023322 BARCO NV CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM 12/23/2002
K013922 BARCO NV CORONIS 3MP MEDICL FLAT PANEL DISPLAY SYSTEM 01/28/2002
K111990 BARCO NV CORONIS 5MP 10/17/2011
K133984 BARCO NV CORONIS 5MP 03/28/2014
K091274 BARCO NV CORONIS 5MP HD, MODEL MDMG 5121 07/14/2009
K093197 BARCO NV CORONIS FUSION 10MP, MODEL MDCG-10130 06/23/2010
K111989 BARCO NV CORONIS FUSION 4MP DL 09/22/2011
K020061 BARCO NV IMAGEDESK 04/03/2002
K023339 BARCO NV IMAGETILE 12/23/2002
K020073 BARCO NV MEDICAL ADMINISTRATOR 07/12/2002
K020058 BARCO NV MEDICAL LE 04/04/2002
K000291 BARCO NV MFCD 118 03/27/2000
K020059 BARCO NV MFCD 118I 04/03/2002
K000294 BARCO NV MFCD 120 03/27/2000
K040158 BARCO NV MFCD 2320 04/12/2004
K091172 BARCO NV NIO 2MP (MDNG-2121) 05/05/2009
K040039 BARCO NV NIO 2MP MEDICAL GRAYSCALE DISPLAY SYSTEM 03/17/2004
K121788 BARCO NV NIO 5MP 07/23/2012
K111991 BARCO NV NIO COLOR 2MP 08/11/2011
K090732 BARCO NV NIO COLOR 3MP AND MDNC-3121 04/20/2009
K131295 BARCO NV NIO COLOR 3MP LED 05/29/2013
K041508 BARCO NV BARCOVIEW BARCOVIEW CORONIS 5MP HD MEDICAL FLAT PANEL DISPLAY SYSTEM 08/27/2004
K033859 BARCO NV BARCOVIEW BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY 06/02/2004
K042221 BARCO NV BARCOVIEW CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM 12/30/2004
K033005 BARCO NV BARCOVIEW MFGD 1318 18 INCH 1 MEGAPIXEL GREYSCALE LCD DISPLAY 04/19/2004
K033004 BARCO NV BARCOVIEW MFGD 2320 20 INCH 2 MEGAPIXEL GREYSCALE LCD DISPLAY 04/16/2004
K033103 BARCO NV BARCOVIEW MGD 2621L MEDICAL GREYSCALE DISPLAY 04/16/2004
K033104 BARCO NV BARCOVIEW MGD 2621P MEDICAL GREYSCALE DISPLAY 04/19/2004
K042942 BARCO NV BARCOVIEW MGP 15 DICOM THEATER 11/22/2004
K033006 BARCO NV BARCOVIEW MIVD 1218 18 INCH GREYSCALE LCD DISPLAY MODULE 04/20/2004
K042660 BARCO NV BARCOVIEW NIO 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM 11/19/2004
K042661 BARCO NV BARCOVIEW NIO 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM 11/19/2004
K040041 BARCO NV BARCOVIEW NIO 3MP MEDICAL GRAYSCALE DISPLAY SYSTEM 03/29/2004
K042662 BARCO NV BARCOVIEW NIO 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM 11/22/2004
K040040 BARCO NV BARCOVIEW NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM 03/29/2004
K982820 BARCO NV DISPLAY SYSTEMS BARCO MEDIS 5MP 5 MEGAPIXEL MEDICAL DIAGNOSTIC DISPLAY SYSTEM 10/08/1998
K001747 BARCO NV DISPLAY SYSTEMS MEDIS 2MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM 07/13/2000
K001751 BARCO NV DISPLAY SYSTEMS MEDIS 2MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM 07/19/2000
K001752 BARCO NV DISPLAY SYSTEMS MEDIS 55MP1H SINGLE-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM 07/19/2000
K001754 BARCO NV DISPLAY SYSTEMS MEDIS 5MP1H DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM 07/19/2000
K001750 BARCO NV DISPLAY SYSTEMS MEDIS 5MP1H QUAD-HEAD MEDICIAL DIAGNOSTIC DISPLAY SYSTEM 07/21/2000
K001753 BARCO NV DISPLAY SYSTEMS MEDIS 5MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM 07/27/2000
K001748 BARCO NV DISPLAY SYSTEMS MEDIS 5MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM 07/27/2000
K052352 BARCOVIEW COLOR CORONIS 2MP-21 AND MFCD 2321 09/30/2005
K052958 BARCOVIEW COLOR NIO 2MP, E-2320 C 11/16/2005
K061926 BARCOVIEW CORONIS 2MP AND MDCG 2121 - CB 08/18/2006
K052403 BARCOVIEW CORONIS 2MP-21 AND MFGD 2621 09/15/2005
K061924 BARCOVIEW CORONIS 3MP AND MDCG 3120-CB 09/05/2006
K052429 BARCOVIEW CORONIS 3MP-21 AND MFGD 3621 09/15/2005
K061928 BARCOVIEW CORONIS COLOR 2MP AND MDCC 2121 09/05/2006
K061927 BARCOVIEW CORONIS COLOR 3MP AND MDCC 3120-DL 09/05/2006
K052529 BARCOVIEW E-2320 PA S 09/30/2005
K051201 BARCOVIEW E1 MEDICAL FLAT PANEL DISPLAY SYSTEM AND MFGD 1218 MEDICAL FLAT PANEL DISPLAY 05/26/2005
K052478 BARCOVIEW MFCD 1219, MFCD 1219 TS 09/28/2005
K052276 BARCOVIEW NIO 2MP-20 AND E-2620 S 09/21/2005
K051902 BARCOVIEW NIO 2MP-21 08/11/2005
K051901 BARCOVIEW NIO 3MP-21 08/17/2005
K062621 BARCOVIEW NIO 5MP-21 AND MDNG-5121 CB 03/19/2007
K062131 BARCOVIEW NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BB 11/17/2006
K062905 BARCOVIEW NIO FUSION 4MP; MDNC 4130 12/29/2006
K061326 BARCOVIEW MIS EDINBURGH VOXAR 3D ENTERPRISE WITH CARDIAMETRIX 05/25/2006
K070831 BARCOVIEW MIS EDINBURGH VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION 05/22/2007
K060505 BARCOVIEW MIS EDINBURGH VOXAR 3D ENTERPRISE, MODEL 6.1 03/29/2006
K081109 BARCOVIEW, MEDICAL IMAGING SYSTEMS CORONIS 5MP MAMMO SL, MODEL MDMG 6121 05/02/2008
K073007 BARCOVIEW, MEDICAL IMAGING SYSTEMS CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL 02/14/2008
K072875 BARCOVIEW, MEDICAL IMAGING SYSTEMS NIO 5MP DISPLAY, MODEL E5620 01/22/2008
K073205 BARCOVIEW, MEDICAL IMAGING SYSTEMS NIO 5MP, MODEL MDNG-5121 12/19/2007
K070726 BARCOVIEW, MEDICAL IMAGING SYSTEMS NIO COLOR 3MP AND MDNC 3120 05/02/2007
K092328 BARTRON MEDICAL IMAGING, INC. MED-SEG, MODEL BTMS 1000 07/26/2010
K173780 Bay Labs, Inc. EchoMD Automated Ejection Fraction Software 06/14/2018
K131299 BEIJING CREALIFE TECHNOLOGY CO., LTD. ANYTHINK PACS WORKSTATION 05/22/2013
K963697 BIO-VASCULAR, INC. ADVANCED DIAGNOSTIC VIEWER (ADV) 11/27/1996
K161109 BIOBOT SURGICAL PTE LTD iSR'obot MRI-US Fusion 10/06/2016
K162559 BIOMET INC. Move Forward 3D Motion Simulation Service 03/31/2017
K101398 BIOSPACE MED STEREOS WORKSTATION 02/04/2011
K090050 BIOSPACE MED STEREOS WORKSTATION 03/05/2010
K080529 BIOSPACE MED STEREOS WORKSTATION 08/29/2008
K063505 BIOTEX, INC. VISUALASE ENVISION SOFTWARE SYSTEM 12/12/2006
K081656 BIOTEX, INC. VISUALASE THERMAL THERAPY SYSTEM 09/10/2008
K063107 BIOTRONICS3D, LTD. 3DNET SUITE 10/27/2006
K142337 BLACKFORD ANALYSIS LTD Blackford Analysis Registration Product Family 03/19/2015
K090607 BLUE SKY BIO, LLC BLUE SKY BIO PLAN, VERSION .38 04/22/2009
K163622 BODY VISION MEDICAL LTD. Lung Vision 05/11/2017
K001596 BOWDENGS TECHNOLOGIES, LLC. LIFERX 07/06/2000
K151957 BOX INC. BOX DICOM Viewer 09/01/2015
K153653 Brainlab AG DICOM Viewer 04/13/2016
K093117 BRAINLAB AG DIGITAL LIGHTBOX 12/11/2009
K170816 Brainlab AG Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM 09/26/2017
K021583 BRAINLAB AG PATXFER 08/12/2002
K141199 BRAINLAB AG QUENTRY DOSE REVIEW 06/20/2014
K132763 BRAINLAB, AG ADVANCED VIEWER 02/28/2014
K080608 BRAINLAB, AG DIGITAL LIGHTBOX 04/17/2008
K040931 BRAINLAB, AG PATXFER RT 07/22/2004
K140828 BRAINREADER APS NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE 02/04/2015
K081168 BRIT SYSTEMS, INC. BRIT PACS SYSTEMS 03/23/2009
K133385 BRONCUS MEDICAL INC LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE 02/26/2014
K112051 BRONCUS TECHNOLOGIES, INC. LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE 10/12/2011
K093423 BRONCUS TECHNOLOGIES, INC. LUNGPOINT PROCEDURE PLANNING 11/17/2009
K091160 BRONCUS TECHNOLOGIES, INC. LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM 05/05/2009
K090095 BRONCUS TECHNOLOGIES, INC. LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM 03/13/2009
K161130 CALGARY SCIENTIFIC, INC. ResolutionMD 08/24/2016
K071086 CALGARY SCIENTIFIC, INC. RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.0 06/01/2007
K133508 CALGARY SCIENTIFIC, INC. RESOLUTIONMD MOBILE 03/26/2014
K123186 CALGARY SCIENTIFIC, INC. RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31 03/14/2013
K111346 CALGARY SCIENTIFIC, INC. RESOLUTIONMD MOBILE MODEL RMB-MOB-2X 09/09/2011
K120076 CALGARY SCIENTIFIC, INC. RESOLUTIONMD WEB 04/19/2012
K082693 CALGARY SCIENTIFIC, INC. RESOLUTIONMD, RELEASE 2.1 02/23/2009
K062164 CALGARY SCIENTIFIC, INC. RESOLUTIONMD, VERSION 1.3 09/22/2006
K051649 CAMTRONICS MEDICAL SYSTEMS VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0 08/02/2005
K954159 CAMTRONICS, LTD. DIGITAL IMAGING SYSTEM 03/19/1996
K992259 CAMTRONICS, LTD. ECHOCARDIOGRAPHY SYSTEM SERIES 95000 09/08/1999
K021236 CAMTRONICS, LTD. SURGERY AND ACCESSORIES 07/17/2002
K992666 CAMTRONICS, LTD. VIDEO PLUS SYSTEM, SERIES 95000 10/13/1999
K111694 CANDELIS, INC. ASTRA 09/15/2011
K080333 CANDELIS, INC. IMAGEGRID 02/22/2008
K092949 CANDELIS, INC. IMAGEGRID RADIOLOGY VIEWER SYSTEM 10/08/2009
K183013 Canon Medical Systems Corporation Vitrea Software Package, VSTP-001A 11/26/2018
K182601 Canon Medical Systems Corporation Vitrea Software Package, VSTP-001A 12/14/2018
K180323 Canon Medical Systems Corporation Vitrea Software Package; VSTP-001A 03/30/2018
K033624 CANON U.S.A., INC. PACS SOFTWARE SOLUTION 2003 12/15/2003
K020449 CARDIONOW, INC. CARDIONOW CARDIOLOGY WIDE AREA ARCHIVE AND RETRIEVAL SYSTEM 05/10/2002
K002597 CARDIONOW, INC. CN ACQUISITION STATION 11/17/2000
K051853 CARDIOSTREAM, LLC CARDIOSTREAM SONOAIM 08/22/2005
K073194 CARDIOVASCULAR IMAGING SOLUTIONS LTD. CMRTOOLS AND PLUG-INS VENTRICULAR TOOLS & THALASSAEMIA TOOLS 02/14/2008
K080770 CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC IMAGENMD WITH IMAGENQ 04/09/2008
K122427 CARESTREAM DENTAL LLC CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE 09/12/2012
K110919 CARESTREAM HEALTH, INC. CARESTREAM PACS 10/20/2011
K083673 CARESTREAM HEALTH, INC. CARESTREAM PACS, MODEL CARESTREAM PACS VII 12/30/2008
K151774 CARESTREAM HEALTH, INC. CARESTREAM Vue Motion 09/21/2015
K153103 CARESTREAM HEALTH, INC. CARESTREAM Vue PACS 02/12/2016
K170580 Carestream Health, Inc. Carestream Vue PACS 04/11/2017
K122523 CARESTREAM HEALTH, INC. CARESTREAM VUE PACS 10/23/2012
K140271 CARESTREAM HEALTH, INC. TABLET VIEWER SOFTWARE FOR IMAGE SUITE 04/01/2014
K132824 CARESTREAM HEALTH,INC. CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION 02/06/2014
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