FDA 510(k) Applications for Medical Device Product Code "KPS"
(System, Tomography, Computed, Emission)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K131625 | ABSOLUTE IMAGING SOLUTIONS | ANYSCAN-S SPECT IMAGING SYSTEM | 10/03/2013 |
| K043293 | ACRORAD CO., LTD. | MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U | 12/17/2004 |
| K980867 | ADAC LABORATORIES | 3D-MSPECT | 06/04/1998 |
| K003434 | ADAC LABORATORIES | ALLEGRO TB, ALLEGRO N | 11/16/2000 |
| K062298 | ADAC LABORATORIES | APOLLO GAMMA CAMERA SYSTEM | 08/23/2006 |
| K040326 | ADAC LABORATORIES | AUTOQUANT PLUS | 02/25/2004 |
| K060020 | ADAC LABORATORIES | AUTOQUANT PLUS | 01/20/2006 |
| K980715 | ADAC LABORATORIES | AUTOQUANT QUANTITATIVE PERFUSION SPECT (QPS) & QUANTITATIVE GATED SPECT (QGS) | 05/06/1998 |
| K042903 | ADAC LABORATORIES | AUTOSPECS | 10/29/2004 |
| K992317 | ADAC LABORATORIES | AUTOSPECT PLUS WITH INSTILL MOTION CORRECTION | 10/01/1999 |
| K982911 | ADAC LABORATORIES | FORTE | 11/16/1998 |
| K033254 | ADAC LABORATORIES | FORTE GAMMA CAMERA SYSTEM | 10/22/2003 |
| K041218 | ADAC LABORATORIES | GRIFFIN SPECT/CT IMAGING SYSTEM | 05/24/2004 |
| K973233 | ADAC LABORATORIES | IMAGE FUSION AND REVIEW SYSTEM | 11/25/1997 |
| K042880 | ADAC LABORATORIES | JETSTREAM WORKSPACE | 11/03/2004 |
| K971980 | ADAC LABORATORIES | MCD-AC | 10/23/1997 |
| K013496 | ADAC LABORATORIES | MODIFICATION TO SKYLIGHT IMAGING SYSTEM | 11/06/2001 |
| K051351 | ADAC LABORATORIES | PRECEDENCE SPECT/CT IMAGING SYSTEM | 06/08/2005 |
| K000908 | ADAC LABORATORIES | SKYLIGHT IMAGING SYSTEM | 04/05/2000 |
| K031705 | ADAC LABORATORIES | SKYLIGHT IMAGING SYSTEM | 06/17/2003 |
| K041182 | ADAC LABORATORIES | SYNTEGRA | 05/21/2004 |
| K031872 | ADAC LABORATORIES | ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC IMAGING] | 06/20/2003 |
| K971878 | ADAC LABORATORIES | VANTAGE 2.1 EXSPECT | 08/08/1997 |
| K991607 | ADAC LABORATORIES | VANTAGE 2.5 | 07/26/1999 |
| K981291 | ADAC LABORATORIES | VANTAGE 3.0 INSYNCH | 06/29/1998 |
| K992078 | ADAC LABORATORIES | VANTAGE EXSPECT II | 09/01/1999 |
| K033735 | ADAC LABORATORIES | VANTAGE PRO ATTENUATION CORRECTION DEVICE | 12/12/2003 |
| K181343 | Bracco Diagnostics Inc. | HeartSee Cardiac P.E.T. Processing Software | 06/12/2018 |
| K191582 | Canon Medical Systems Corporation | Cartesion Prime | 08/13/2019 |
| K231748 | Canon Medical Systems Corporation | Cartesion Prime (PCD-1000A/3) V10.15 | 09/12/2023 |
| K203314 | Canon Medical Systems Corporation | Cartesion Prime (PCD-1000A/3) V10.8 | 04/23/2021 |
| K202349 | Canon Medical Systems Corporation | Cartesion Prime, PCD-1000A, V10.7 | 10/15/2020 |
| K053062 | CARDIARC LTD. | CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2 | 01/06/2006 |
| K122241 | CARDIOVASCULAR IMAGING TECHNOLOGIES | IMAGEN3D | 10/24/2012 |
| K152503 | CARDIOVASCULAR IMAGING TECHNOLOGIES | ImagenSPECT | 01/25/2016 |
| K201933 | Cardiovascular Imaging Technologies | ImagenSPECT 3.0 | 08/11/2020 |
| K173547 | Cardiovascular Imaging Technologies | ImagenUniversal | 01/12/2018 |
| K041671 | CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC | IMAGENMD | 07/22/2004 |
| K050366 | CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC | IMAGENPRO | 03/17/2005 |
| K123433 | CEDARS-SINAI MEDICAL CENTER | CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE | 02/26/2013 |
| K141652 | CEDARS-SINAI MEDICAL CENTER | CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE | 07/22/2014 |
| K172609 | Cedars-Sinai Medical Center | CSMC Cardiac Suite | 11/03/2017 |
| K112474 | CEDARS-SINAI MEDICAL CENTER | CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE | 09/23/2011 |
| K100714 | CEDARS-SINAI MEDICAL CENTER | CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01 | 04/01/2011 |
| K231576 | Combinostics Oy | cNeuro cPET | 09/14/2023 |
| K981027 | CTI PET SYSTEMS, INC. | E.CAM LSO 311 PET/SPECT SYSTEM | 06/08/1998 |
| K002584 | CTI PET SYSTEMS, INC. | ECAT ACCEL PET SCANNER | 11/16/2000 |
| K962797 | CTI PET SYSTEMS, INC. | ECAT EXACT & ECAT EXACT HR+ | 10/15/1996 |
| K040933 | CTI PET SYSTEMS, INC. | ECAT HRRT | 06/07/2004 |
| K023518 | CTI PET SYSTEMS, INC. | ECAT LSO PET/CT 16 | 11/08/2002 |
| K002715 | CTI PET SYSTEMS, INC. | ECAT PET SCANNER | 10/31/2000 |
| K003241 | CTI PET SYSTEMS, INC. | ECAT PET SCANNER | 12/13/2000 |
| K974256 | CTI PET SYSTEMS, INC. | ECAT PET SCANNERS | 02/25/1998 |
| K023768 | CTI PET SYSTEMS, INC. | ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 16 | 11/25/2002 |
| K021633 | CTI PET SYSTEMS, INC. | ECAT VISION PET SCANNER, MODELS 3000 & 5000 | 08/14/2002 |
| K042467 | CTI PET SYSTEMS, INC. | LSO PET/CT HIREZ 64 | 10/01/2004 |
| K033431 | CTI PET SYSTEMS, INC. | LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ | 11/20/2003 |
| K050509 | CTI PET SYSTEMS, INC. | LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I | 03/25/2005 |
| K013504 | CTI PET SYSTEMS, INC. | MODIFICATION TO: ECAT LSO PET/CT SCANNER | 10/31/2001 |
| K031825 | DANISH DIAGNOSTIC DEVELOPMENT A/S | C.CAM | 06/20/2003 |
| K051460 | DANISH DIAGNOSTIC DEVELOPMENT A/S | C.CAM-AC | 06/15/2005 |
| K011611 | DANISH DIAGNOSTIC DEVELOPMENT A/S | CARDIOCAM MODEL 9CSY0799 | 06/08/2001 |
| K040616 | DANISH DIAGNOSTIC DEVELOPMENT A/S | CARDIOMD-AC | 03/24/2004 |
| K001888 | DANISH DIAGNOSTIC DEVELOPMENT A/S | UNICORN MODEL SYS0630 | 06/30/2000 |
| K161674 | DDD-DIAGNOSTIC A/S | QuantumCam | 10/20/2016 |
| K140206 | DDD-DIAGNOSTIC A/S | SCINTILLATION GAMMA CAMERA | 05/08/2014 |
| K070542 | DIGIRAD CORP. | CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS | 03/23/2007 |
| K083649 | DIGIRAD CORP. | CARDIUS 3 X-ACT | 03/09/2009 |
| K030085 | DIGIRAD CORP. | CARDIUS-1 AND CARDIS-2 | 02/05/2003 |
| K082368 | DIGIRAD CORP. | CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT IMAGING SYSTEM | 09/12/2008 |
| K051549 | DIGIRAD CORP. | CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM | 07/13/2005 |
| K052430 | DIGIRAD CORP. | CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM | 10/04/2005 |
| K023110 | DIGIRAD CORP. | CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005 | 11/22/2002 |
| K982855 | DIGIRAD CORP. | DIGIRAD 2020TC SPECT IMAGING SYSTEM | 11/04/1998 |
| K011572 | DIGIRAD CORP. | QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS) | 06/15/2001 |
| K082904 | DIGIRAD CORP. | STASYS MOTION CORRECTION SOFTWARE | 12/17/2008 |
| K073021 | EAGLE HEART IMAGING, LLC | MULTI-SPECT | 11/06/2007 |
| K032500 | ECLIPSE SYSTEMS, INC. | MODIFICARION TO WACKERS-LIU CQ SOFTWARE | 08/25/2003 |
| K002229 | ECLIPSE SYSTEMS, INC. | WACKERS-LIU CQ SOFTWARE | 10/20/2000 |
| K963162 | ELSCINT, INC. | QUANTEM | 11/12/1996 |
| K962100 | ELSCINT, INC. | VOLMETRIC COINCIDENCE DETECTION SYSTEM | 01/10/1997 |
| K980914 | EMORY UNIVERSITY | EMORY CARDIAC TOOL BOX | 06/04/1998 |
| K992450 | EMORY UNIVERSITY | EMORY CARDIAC TOOLBOX* 2.0 EXECUTING ON NUCLEAR MEDICINE COMPUTERS | 10/07/1999 |
| K213731 | Ever Fortune.AI Co., Ltd. | EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows | 05/31/2022 |
| K970970 | FOCUS MEDICAL SA | CARDIOMATCH | 06/13/1997 |
| K113350 | GE HEALTHCARE | BRIVO NM 615 | 12/05/2011 |
| K111445 | GE HEALTHCARE | DISCOVERY NM 630 | 06/03/2011 |
| K153402 | GE HEALTHCARE | Discovery NM/CT 670 CZT | 01/21/2016 |
| K061587 | GE HEALTHCARE | FULLCARD ANALYSIS | 06/23/2006 |
| K041543 | GE HEALTHCARE | GE DISCOVERY ST | 06/22/2004 |
| K062393 | GE HEALTHCARE | GE VANTAGE PET NEURO SOFTWARE | 09/01/2006 |
| K212004 | GE Healthcare | MyoSPECT, MyoSpect ES | 08/27/2021 |
| K173816 | GE Healthcare | NM/CT 850, NM/CT 860 | 04/17/2018 |
| K221932 | GE Healthcare | Omni Legend | 09/02/2022 |
| K121019 | GE HEALTHCARE | OPTIMA NM/CT 640 | 04/19/2012 |
| K223212 | GE Healthcare | Precision DL | 04/27/2023 |
| K210173 | GE Healthcare | StarGuide | 03/29/2021 |
| K023988 | GE MEDICAL SYSTEMS | GE DISCOVERY LS SYSTEM | 02/04/2003 |
| K041220 | GE MEDICAL SYSTEMS | GE DISCOVERY ST SYSTEM | 06/15/2004 |
| K050559 | GE MEDICAL SYSTEMS | GE DISCOVERY VCT SYSTEM | 03/17/2005 |
| K012775 | GE MEDICAL SYSTEMS | GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER | 09/18/2001 |
| K964012 | GE MEDICAL SYSTEMS | GENIE PROCESSING AND REVIEW WORKSTATION | 01/07/1997 |
| K052434 | GE MEDICAL SYSTEMS | HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA | 09/27/2005 |
| K962738 | GE MEDICAL SYSTEMS | MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS | 10/10/1996 |
| K040172 | GE MEDICAL SYSTEMS | MODIFICATION TO GE DISCOVERY LS SYSTEM | 04/07/2004 |
| K954874 | GE MEDICAL SYSTEMS | SPECTEF PROTOCOL | 02/26/1996 |
| K994167 | GE MEDICAL SYSTEMS F.I. HAIFA | CODE AC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA WITH COINCIDENCE OPTION (CODE) | 03/07/2000 |
| K093514 | GE MEDICAL SYSTEMS F.I. HAIFA | DISCOVERY MODEL NM/CT 670 | 12/10/2009 |
| K083504 | GE MEDICAL SYSTEMS F.I. HAIFA | GE DISCOVERY NM/CT 570C | 12/12/2008 |
| K023932 | GE MEDICAL SYSTEMS F.I. HAIFA | GE PHOTON ENERGY RECOVERY (PER) OPTION | 12/11/2002 |
| K022960 | GE MEDICAL SYSTEMS F.I. HAIFA | GE QUASAR NUCLEAR MEDICINE SYSTEM | 09/19/2002 |
| K991841 | GE MEDICAL SYSTEMS F.I. HAIFA | HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA | 08/26/1999 |
| K043381 | GE MEDICAL SYSTEMS F.I. HAIFA | INFINIA LIGHTSPEED | 12/23/2004 |
| K991896 | GE MEDICAL SYSTEMS F.I. HAIFA | MG ATC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA | 08/23/1999 |
| K033874 | GE MEDICAL SYSTEMS F.I. HAIFA | MYOLIGHT | 12/30/2003 |
| K003264 | GE MEDICAL SYSTEMS F.I. HAIFA | QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION | 12/21/2000 |
| K051855 | GE MEDICAL SYSTEMS F.I. HAIFA | VENTRI | 08/02/2005 |
| K080124 | GE MEDICAL SYSTEMS F.I. HAIFA | VENTRI 1.1 | 01/31/2008 |
| K981352 | GE MEDICAL SYSTEMS F.I. HAIFA | VPC-94 ULTRA HIGH ENERGY COLLIMATERS MODEL NUMBERS 480-685-9402 | 07/13/1998 |
| K980959 | GE MEDICAL SYSTEMS F.I. HAIFA | VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA | 06/04/1998 |
| K192277 | GE Medical Systems SCS | CardIQ Flow | 02/14/2020 |
| K222895 | GE Medical Systems SCS | DynamicIQ | 11/22/2022 |
| K211247 | GE Medical Systems SCS | PET VCAR | 07/27/2021 |
| K003849 | GE MEDICAL SYSTEMS, INC. | GE ADVANCE NXI PET SYSTEM | 12/22/2000 |
| K022240 | GE MEDICAL SYSTEMS, INC. | MOBILE MILLENNIUM MG SYSTEM | 08/06/2002 |
| K161574 | GE Medical Systems, L.L.C. | Discovery MI | 08/11/2016 |
| K141074 | GE MEDICAL SYSTEMS, LLC | CORTEX ID SUITE | 09/18/2014 |
| K141477 | GE MEDICAL SYSTEMS, LLC | DISCOVERY IQ | 09/18/2014 |
| K133657 | GE MEDICAL SYSTEMS, LLC | DISCOVERY PET/CT 710 | 03/21/2014 |
| K081496 | GE MEDICAL SYSTEMS, LLC | OPTIMA PET/CT 560 | 06/12/2008 |
| K180318 | GE Medical Systems, LLC | PET Digital Gating | 04/11/2018 |
| K113408 | GE MEDICAL SYSTEMS, LLC | Q. FREEZE (MOTION VUE2) | 02/24/2012 |
| K211846 | GE Medical Systems, LLC. | Discovery MI Gen2 | 08/20/2021 |
| K042257 | GENERAL ELECTRIC CO. | DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION | 09/08/2004 |
| K030199 | GENERAL ELECTRIC CO. | GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM | 02/11/2003 |
| K022872 | GENERAL ELECTRIC CO. | GE ROAD WARRIOR PET CT IMAGING SYSTEM | 09/12/2002 |
| K012568 | GENERAL ELECTRIC CO. | GE VISION NUCLEAR MEDICINE WORKSTATION | 09/06/2001 |
| K161631 | GENERAL EQUIPMENT FOR MEDICAL IMAGING | MAMMI | 07/28/2016 |
| K140996 | GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION- | MAMMI | 06/11/2014 |
| K232569 | General Equipment for Medical Imaging, S.A. | CAREMIBRAIN | 09/21/2023 |
| K072191 | GVI TECHNOLOGY PARTNERS | CLEARVISION NUCLEAR MEDICINE IMAGING SYSTEM | 10/25/2007 |
| K982171 | HAMAMATSU PHOTONICS, K.K. | HAMAMATSU PET SCANNER, MODEL SHR-22000 | 09/17/1998 |
| K193152 | Hermes Medical Solutions AB | Affinity | 02/14/2020 |
| K202882 | Hermes Medical Solutions AB | Affinity | 12/23/2020 |
| K171681 | Hermes Medical Solutions AB | Hermes Medical Imaging Suite v5.7 | 11/21/2017 |
| K163394 | Hermes Medical Solutions AB | Hybrid3D | 05/22/2017 |
| K171719 | Hermes Medical Solutions AB | Hybrid3D | 11/21/2017 |
| K181468 | Hermes Medical Solutions AB | Hybrid3D | 10/25/2018 |
| K121278 | HERMES MEDICAL SOLUTIONS, AB | HERMES MEDICAL IMAGING SUITE V5.2 | 12/18/2012 |
| K131233 | HERMES MEDICAL SOLUTIONS, AB | HERMES MEDICAL IMAGING SUITE V5.3 | 07/16/2013 |
| K140269 | HERMES MEDICAL SOLUTIONS, AB | HERMES MEDICAL IMAGING SUITE V5.4 | 05/08/2014 |
| K142631 | HERMES MEDICAL SOLUTIONS, AB | Hermes Medical Imaging Suite v5.5 | 12/18/2014 |
| K153056 | HERMES MEDICAL SOLUTIONS, AB | Hermes Medical Imaging Suite v5.6 | 06/01/2016 |
| K991535 | HITACHI MEDICAL CORP. OF AMERICA | CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS | 07/30/1999 |
| K991318 | HITACHI MEDICAL CORP. OF AMERICA | CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS | 06/18/1999 |
| K991129 | HITACHI MEDICAL CORP. OF AMERICA | HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL | 05/13/1999 |
| K042428 | HITACHI MEDICAL SYSTEMS AMERICA, INC. | SCEPTREP3 PET/CT | 09/17/2004 |
| K132347 | INTER MEDICAL MEDIZINTECHNIK GMBH | MULTICAM 3000 ECO | 11/20/2013 |
| K080575 | INVIA | CORRIDOR4DM | 05/13/2008 |
| K033199 | IS2 MEDICAL SYSTEMS, INC. | COMPACT DIGITAL CARDIAC CAMERA (CDCC) | 11/12/2003 |
| K013667 | IS2 RESEARCH, INC. | BCC GAMMA CAMERA | 01/28/2002 |
| K040057 | IS2 RESEARCH, INC. | MOBILE COMPACT DIGITAL CARDIAC CAMERA | 02/02/2004 |
| K033956 | IS2 RESEARCH, INC. | MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC) | 01/20/2004 |
| K032779 | IS2 RESEARCH, INC. | MODIFICATION TO: NUCAMMA RX | 12/17/2003 |
| K003882 | IS2 RESEARCH, INC. | NUCAMMA BI90 | 02/21/2001 |
| K982044 | IS2 RESEARCH, INC. | NUCAMMA R+ | 09/02/1998 |
| K982045 | IS2 RESEARCH, INC. | NUCAMMA RX | 09/02/1998 |
| K965226 | LUNAR CORP. | EXPERT-XL TOTAL BODY ACQUISITION AND ANALYSIS SOFTWARE | 10/03/1997 |
| K202679 | McGovern Medical School | Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 | 04/12/2021 |
| K231731 | McGovern Medical School | Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 | 08/21/2023 |
| K962955 | MEDICAL IMAGING TECHNOLOGY ASSOC., INC. | GAMMACON IMAGE TRANSLATION SYSTEM | 10/28/1996 |
| K082581 | MEDX, INC. | C-QUEST | 11/14/2008 |
| K993893 | MEDX, INC. | MEDX INTECAM INTERFACE | 02/10/2000 |
| K041840 | MEDX, INC. | MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM | 08/20/2004 |
| K053086 | MIE AMERICA, INC. | MIE - GAMMA CAMERA SYSTEMS | 01/27/2006 |
| K130269 | MIE GMBH | ECAT SCINTRON PET | 04/19/2013 |
| K101768 | MIE GMBH | MIE SCINTRON GAMMA CAMERA SYSTEMS | 10/05/2010 |
| K101013 | MIE GMBH | MODIFICATION TO SCINTRON IV | 06/07/2010 |
| K201807 | MiEGmbH | ANCORIS | 08/27/2020 |
| K082354 | NAVISCAN PET SYSTEMS | STEREO NAVIGATOR ACCESSORY, STN-1000 | 11/18/2008 |
| K090553 | NAVISCAN, INC. | NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER | 03/31/2009 |
| K090811 | NEUROLOGICA CORPORATION | INSPIRA HD, MODEL: NL1000 | 08/27/2009 |
| K151403 | NEUSOFT MEDICAL SYSTEMS CO., LTD. | Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System | 11/02/2015 |
| K090178 | NEUSOFT POSITRON MEDICAL SYSTEMS CO., LTD | ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8 | 04/24/2009 |
| K972509 | NUCCARDIAC SOFTWARE, INC. | CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL SYSTEMS COMPUTER | 09/08/1997 |
| K970288 | NUCCARDIAC SOFTWARE, INC. | CLINICAL DIAGNOSTIC SOFTWARE | 04/24/1997 |
| K021823 | NUCLEAR CARDIOLOGY SYSTEMS, INC. | CARDIOSPECT D90/CARDIO CAM | 06/17/2002 |
| K013353 | NUCLEAR CARDIOLOGY SYSTEMS, INC. | NEUROSPECTQUAD GAMMA CAMERA | 03/04/2002 |
| K021656 | NUCLEAR DIAGNOSTICS | HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4 | 06/13/2002 |
| K974444 | NUMA, INC. | NUMASTATION | 02/13/1998 |
| K970128 | PARK MEDICAL SYSTEMS, INC. | ISOCAM I (SINGLE HEAD GAMMA CAMERA)/ISOCAM II (DUAL HEAD GAMMA CAMERA) | 04/11/1997 |
| K964834 | PARK MEDICAL SYSTEMS, INC. | ISOCAM II (DUAL HEAD GAMMA CAMERA) | 02/28/1997 |
| K032063 | PEM TECHNOLOGIES | PEM 2400 PET SCANNER | 08/18/2003 |
| K123599 | PHILIPS HEALTHCARE (CLEVELAND) | INGENUITY DIGITAL PET/CT | 07/12/2013 |
| K172406 | Philips Medical Systems (Cleveland) Inc. | Ingenuity TF | 10/06/2017 |
| K210880 | Philips Medical Systems Nederland B.V. | Vereos PET/CT | 05/19/2021 |
| K211764 | Philips Medical Systems Nederland B.V. | Vereos PET/CT | 08/06/2021 |
| K033782 | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. | ALLEGRO IMAGING SYSTEM | 12/19/2003 |
| K090403 | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. | AUTOSPECT | 03/31/2009 |
| K992335 | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. | BEACON-P, MODEL 211059 | 10/07/1999 |
| K983948 | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. | BEACON, MODEL 211060 | 04/16/1999 |
| K080927 | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. | BRIGHTVIEW VCT IMAGING SYSTEM | 04/11/2008 |
| K042839 | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. | C-PET PLUS IMAGING SYSTEM | 10/29/2004 |
| K032036 | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. | GEMINI 16 | 07/11/2003 |
| K081135 | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. | GEMINI CONDOR | 04/29/2008 |
| K042935 | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. | GEMINI GXL | 11/09/2004 |
| K051170 | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. | GEMINI GXL | 05/23/2005 |
| K041955 | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. | GEMINI PET/CT IMAGING SYSTEM | 07/29/2004 |
| K052640 | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. | GEMINI RAPTOR | 10/07/2005 |
| K081426 | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. | NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE | 06/04/2008 |
| K960192 | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. | POSITRON COINCIDENCE DETECTION | 09/12/1996 |
| K961577 | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. | PRISM 3000XPV SYSTEM (210714) | 07/23/1996 |
| K964712 | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. | PRISM XPVT SYSTEM (210823) | 02/21/1997 |
| K960865 | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. | STEP OPTION TO PRISM 2000 | 09/20/1996 |
| K963406 | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. | UHE COLLIMATOR (210591) | 02/26/1997 |
| K955484 | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. | XENON OPTION TO PRISM 3000 | 03/29/1996 |
| K091269 | PHOTODETECTION SYSTEMS, INC. | NEUROPET | 05/08/2009 |
| K022001 | POSITRON CORP. | MPOWER, MODEL 712 SERIES | 07/12/2002 |
| K210450 | Prescient Imaging, LLC | BBX-PET Scanner | 03/17/2021 |
| K963730 | PROPORTIONAL TECHNOLOGIES, INC. | PROTEC (1024) | 02/10/1997 |
| K214062 | Radialis Inc. | Radialis PET Camera | 02/04/2022 |
| K043441 | SEGAMI CORPORATION | MIRAGE, RELEASE 5.5 | 01/13/2005 |
| K193241 | Shanghai United Imaging Healthcare Co., Ltd | Emission Computed Tomography System | 01/26/2020 |
| K182938 | Shanghai United Imaging Healthcare Co., Ltd. | Emission Computed Tomography System | 12/18/2018 |
| K193210 | Shanghai United Imaging Healthcare Co., Ltd. | HYPER DLR | 08/04/2020 |
| K182237 | Shanghai United Imaging Healthcare Co., Ltd. | uMI 550 PET/CT System | 10/12/2018 |
| K232712 | Shanghai United Imaging Healthcare Co., Ltd. | uMI Panorama | 10/03/2023 |
| K223325 | Shanghai United Imaging Healthcare Co., Ltd. | uMI Panorama | 03/10/2023 |
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