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KPS

472 FDA 510(k) clearances · Product code

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RecordFirmDate
Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT (K162736)Siemens Medical Solutions USA, Inc.2016-10-25
QuantumCam (K161674)Ddd-Diagnostic A/S2016-10-20
Symbia 6.5 (K162337)Siemens Medical Solutions USA, Inc.2016-09-08
Discovery MI (K161574)Ge Medical Systems, LLC2016-08-11
MAMMI (K161631)General Equipment For Medical Imaging2016-07-28
Hermes Medical Imaging Suite v5.6 (K153056)Hermes Medical Solutions AB2016-06-01
D-SPECT Processing and Reviewing Workstation (K160120)Spectrum Dynamics , Ltd.2016-03-21
ImagenSPECT (K152503)Cardiovascular Imaging Technologies2016-01-25
Discovery NM/CT 670 CZT (K153402)GE Healthcare2016-01-21
Biograph Horizon PET/CT (K152880)Siemens Medical Solutions USA, Inc.2016-01-12
Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System (K151403)Neusoft Medical Systems Co., Ltd.2015-11-02
Biograph mCT and mCT Flow PET/CT Scanners (K151486)Siemens Medical Solutions USA, Inc.2015-07-17
HeartSee (K143664)University of Texas Medical School AT Houston2015-04-14
Hermes Medical Imaging Suite v5.5 (K142631)Hermes Medical Solutions AB2014-12-18
CORTEX ID SUITE (K141074)Ge Medical Systems, LLC2014-09-18
DISCOVERY IQ (K141477)Ge Medical Systems, LLC2014-09-18
BIOGRAPH TRUE PET/CT FAMILY SOFTWARE (K141971)Siemens Medical Solutions USA, Inc.2014-09-12
SYMBIA 6.0 (K142006)Siemens Medical Solutions USA, Inc.2014-08-21
CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE (K141652)Cedars-Sinai Medical Center2014-07-22
CELESTEION, PCA-9000A/2 (K140651)Toshibamedical Systems Corporation2014-06-11
MAMMI (K140996)General Equipment For Medical Imaging (Oncovision-2014-06-11
HERMES MEDICAL IMAGING SUITE V5.4 (K140269)Hermes Medical Solutions AB2014-05-08
SCINTILLATION GAMMA CAMERA (K140206)Ddd-Diagnostic A/S2014-05-08
DISCOVERY PET/CT 710 (K133657)Ge Medical Systems, LLC2014-03-21
MULTICAM 3000 ECO (K132347)Inter Medical Medizintechnik GmbH2013-11-20
ANYSCAN-S SPECT IMAGING SYSTEM (K131625)Absolute Imaging Solutions2013-10-03
SYMBIA (K131634)Siemens Medical Solutions USA, Inc.2013-08-16
HERMES MEDICAL IMAGING SUITE V5.3 (K131233)Hermes Medical Solutions AB2013-07-16
INGENUITY DIGITAL PET/CT (K123599)Philips Healthcare (Cleveland)2013-07-12
EMORY CARDIAC TOOLBOX 3.2 (K130902)Syntermed, Inc.2013-06-14
NEUROQ 3.6 (K130451)Syntermed, Inc.2013-05-17
ECAT SCINTRON PET (K130269)Miegmbh2013-04-19
CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE (K123433)Cedars-Sinai Medical Center2013-02-26
EMORY CARDIAC TOOLBOX 4.0 (K123646)Syntermed, Inc.2013-02-22
BIOGRAPH MCT FAMILY (K123737)Siemens Medical Solutions USA, Inc.2013-01-29
HERMES MEDICAL IMAGING SUITE V5.2 (K121278)Hermes Medical Solutions AB2012-12-18
IMAGEN3D (K122241)Cardiovascular Imaging Technologies2012-10-24
CFR QUANT (K113754)University of Texas Medical School AT Houston2012-07-19
OPTIMA NM/CT 640 (K121019)GE Healthcare2012-04-19
Q. FREEZE (MOTION VUE2) (K113408)Ge Medical Systems, LLC2012-02-24
ACQA (K113086)Texas Medical Imaging Consultants2012-01-13
BIOGRAPH MCT FAMILY (K113448)Siemens Medical Solutions USA, Inc.2011-12-17
BRIVO NM 615 (K113350)GE Healthcare2011-12-05
CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE (K112474)Cedars-Sinai Medical Center2011-09-23
CARDIAC SCANNER AND PROCESSING SYSTEM (K110507)Spectrum Dynamics (Israel) , Ltd.2011-07-13
DISCOVERY NM 630 (K111445)GE Healthcare2011-06-03
CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01 (K100714)Cedars-Sinai Medical Center2011-04-01
WBR XPRESS PET (K103710)Ultraspect , Ltd.2011-01-19
MIE SCINTRON GAMMA CAMERA SYSTEMS (K101768)Miegmbh2010-10-05
BIOGRAPH MCT FAMILY (K101550)Siemens Medical Solutions USA, Inc.2010-09-03
MODIFICATION TO SCINTRON IV (K101013)Miegmbh2010-06-07
DISCOVERY MODEL NM/CT 670 (K093514)Ge Medical Systems F.I. Haifa2009-12-10
INSPIRA HD, MODEL: NL1000 (K090811)Neurologica Corporation2009-08-27
WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS (K091073)Ultraspect , Ltd.2009-05-14
NEUROPET (K091269)Photodetection Systems, Inc.2009-05-08
ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8 (K090178)Neusoft Positron Medical Systems Co., Ltd.2009-04-24
AUTOSPECT (K090403)Philips Medical Systems (Cleveland), Inc.2009-03-31
NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER (K090553)Naviscan, Inc.2009-03-31
BIOGRAPH 16 TRUE POINT SYSTEMS (K083852)Siemens Medical Solutions USA, Inc.2009-03-23
CARDIUS 3 X-ACT (K083649)Digirad Corp.2009-03-09
STASYS MOTION CORRECTION SOFTWARE (K082904)Digirad Corp.2008-12-17
GE DISCOVERY NM/CT 570C (K083504)Ge Medical Systems F.I. Haifa2008-12-12
SYMBIA, VERSION 4.0 (K082506)Siemens Medical Solutions USA, Inc.2008-11-21
STEREO NAVIGATOR ACCESSORY, STN-1000 (K082354)Naviscan Pet Systems2008-11-18
C-QUEST (K082581)Medx, Inc.2008-11-14
CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT IMAGING SYSTEM (K082368)Digirad Corp.2008-09-12
PCA-8000A, MARK 11, PET / CT SYSTEM (K082244)Toshiba America Medical Systems, In.C2008-08-21
BIOGRAPH HD FAMILY (K081453)Siemens Medical Solutions USA, Inc.2008-06-23
OPTIMA PET/CT 560 (K081496)Ge Medical Systems, LLC2008-06-12
NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE (K081426)Philips Medical Systems (Cleveland), Inc.2008-06-04
WBR XPRESS3.CARDIAC (K081201)Ultraspect , Ltd.2008-05-28
CORRIDOR4DM (K080575)Invia2008-05-13
GEMINI CONDOR (K081135)Philips Medical Systems (Cleveland), Inc.2008-04-29
BRIGHTVIEW VCT IMAGING SYSTEM (K080927)Philips Medical Systems (Cleveland), Inc.2008-04-11
WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE (K080784)Ultraspect , Ltd.2008-04-02
QUANTITATIVE NEUROQ 3.0 (K072307)Syntermed, Inc.2008-03-14
VENTRI 1.1 (K080124)Ge Medical Systems F.I. Haifa2008-01-31
MULTI-SPECT (K073021)Eagle Heart Imaging, LLC2007-11-06
SYMBIA-E, MODEL 10275879 (K072567)Siemens Medical Solutions USA, Inc.2007-10-30
CLEARVISION NUCLEAR MEDICINE IMAGING SYSTEM (K072191)Gvi Technology Partners2007-10-25
MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM (K072468)Spectrum Dynamics , Ltd.2007-10-01
SYSTEM, TOMOGRAPHY, COMPUTED EMISSION (K071503)Syntermed, Inc.2007-07-26
BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197 (K071068)Siemens Medical Solutions USA, Inc.2007-05-14
C! (K070589)Transphoton Corporation2007-04-24
CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS (K070542)Digirad Corp.2007-03-23
D-SPECT CARDIAC SCANNER SYSTEM (K062450)Spectrum Dynamics , Ltd.2006-10-20
GE VANTAGE PET NEURO SOFTWARE (K062393)GE Healthcare2006-09-01
APOLLO GAMMA CAMERA SYSTEM (K062298)Adac Laboratories2006-08-23
SCENIUM 1.1 (K061545)Siemens Molecular Imaging, Ltd.2006-06-30
FULLCARD ANALYSIS (K061587)GE Healthcare2006-06-23
CYCLONE, MODEL MAICAM 180 (K060486)Spectrica2006-03-23
BIOGRAPH 64 AND BIOGRAPH 40 (K060631)Siemens Medical Solutions USA, Inc.2006-03-17
BIOGRAPH 6 (K060060)Siemens Medical Solutions USA, Inc.2006-02-03
MIE - GAMMA CAMERA SYSTEMS (K053086)Mie America, Inc.2006-01-27
AUTOQUANT PLUS (K060020)Adac Laboratories2006-01-20
CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2 (K053062)Cardiarc , Ltd.2006-01-06
GEMINI RAPTOR (K052640)Philips Medical Systems (Cleveland), Inc.2005-10-07
CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM (K052430)Digirad Corp.2005-10-04
HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA (K052434)GE Medical Systems2005-09-27
VENTRI (K051855)Ge Medical Systems F.I. Haifa2005-08-02
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