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KPS

472 FDA 510(k) clearances · Product code

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RecordFirmDate
CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM (K051549)Digirad Corp.2005-07-13
C.CAM-AC (K051460)Danish Diagnostic Development A/S2005-06-15
PRECEDENCE SPECT/CT IMAGING SYSTEM (K051351)Adac Laboratories2005-06-08
GEMINI GXL (K051170)Philips Medical Systems (Cleveland), Inc.2005-05-23
XACT.CARDIAC & XPRESS.CARDIAC (K050815)Ultraspect , Ltd.2005-04-26
LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I (K050509)Cti Pet Systems, Inc.2005-03-25
IMAGENPRO (K050366)Cardiovascular Imaging Technologies, LLC2005-03-17
GE DISCOVERY VCT SYSTEM (K050559)GE Medical Systems2005-03-17
MIRAGE, RELEASE 5.5 (K043441)Segami Corporation2005-01-13
INFINIA LIGHTSPEED (K043381)Ge Medical Systems F.I. Haifa2004-12-23
MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U (K043293)Acrorad Co., Ltd.2004-12-17
SCENIUM (K042863)Siemens Molecular Imaging, Ltd.2004-12-15
GEMINI GXL (K042935)Philips Medical Systems (Cleveland), Inc.2004-11-09
JETSTREAM WORKSPACE (K042880)Adac Laboratories2004-11-03
C-PET PLUS IMAGING SYSTEM (K042839)Philips Medical Systems (Cleveland), Inc.2004-10-29
AUTOSPECS (K042903)Adac Laboratories2004-10-29
BP-SPECT V1.O (K042258)Syntermed, Inc.2004-10-04
LSO PET/CT HIREZ 64 (K042467)Cti Pet Systems, Inc.2004-10-01
SCEPTREP3 PET/CT (K042428)Hitachi Medical Systems America, Inc.2004-09-17
DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION (K042257)General Electric Co.2004-09-08
MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM (K041840)Medx, Inc.2004-08-20
GEMINI PET/CT IMAGING SYSTEM (K041955)Philips Medical Systems (Cleveland), Inc.2004-07-29
IMAGENMD (K041671)Cardiovascular Imaging Technologies, LLC2004-07-22
GE DISCOVERY ST (K041543)GE Healthcare2004-06-22
NEUROQ - PET DP (K041022)Syntermed, Inc.2004-06-17
GE DISCOVERY ST SYSTEM (K041220)GE Medical Systems2004-06-15
ECAT HRRT (K040933)Cti Pet Systems, Inc.2004-06-07
GRIFFIN SPECT/CT IMAGING SYSTEM (K041218)Adac Laboratories2004-05-24
SYNTEGRA (K041182)Adac Laboratories2004-05-21
SIEMENS ENHANCED IMAGING SYSTEM (K041166)Siemens Medical Solutions USA, Inc.2004-05-17
MODIFICATION TO GE DISCOVERY LS SYSTEM (K040172)GE Medical Systems2004-04-07
CARDIOMD-AC (K040616)Danish Diagnostic Development A/S2004-03-24
WBR-FHR, WBR-FWB (K040370)Ultraspect , Ltd.2004-03-11
AUTOQUANT PLUS (K040326)Adac Laboratories2004-02-25
MOBILE COMPACT DIGITAL CARDIAC CAMERA (K040057)Is2 Research, Inc.2004-02-02
EMORY CARDIAC TOOLBOX VERSION 2.6 (K040141)Syntermed, Inc.2004-01-30
MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC) (K033956)Is2 Research, Inc.2004-01-20
MYOLIGHT (K033874)Ge Medical Systems F.I. Haifa2003-12-30
APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4 (K033001)Transphoton Corporation2003-12-24
ALLEGRO IMAGING SYSTEM (K033782)Philips Medical Systems (Cleveland), Inc.2003-12-19
MODIFICATION TO: NUCAMMA RX (K032779)Is2 Research, Inc.2003-12-17
VANTAGE PRO ATTENUATION CORRECTION DEVICE (K033735)Adac Laboratories2003-12-12
CLARITY PET (K032866)Shared P.E.T. Imaging, LLC2003-12-12
LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ (K033431)Cti Pet Systems, Inc.2003-11-20
COMPACT DIGITAL CARDIAC CAMERA (CDCC) (K033199)Is2 Medical Systems, Inc.2003-11-12
FORTE GAMMA CAMERA SYSTEM (K033254)Adac Laboratories2003-10-22
MODIFICARION TO WACKERS-LIU CQ SOFTWARE (K032500)Eclipse Systems, Inc.2003-08-25
PEM 2400 PET SCANNER (K032063)Pem Technologies2003-08-18
MODIFICATION TO WBR, MODEL HR (K031874)U.C.G. Technologies , Ltd.2003-07-18
GEMINI 16 (K032036)Philips Medical Systems (Cleveland), Inc.2003-07-11
C.CAM (K031825)Danish Diagnostic Development A/S2003-06-20
ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC IMAGING] (K031872)Adac Laboratories2003-06-20
SKYLIGHT IMAGING SYSTEM (K031705)Adac Laboratories2003-06-17
WBR, MODEL HR (K030870)U.C.G. Technologies , Ltd.2003-04-09
GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM (K030199)General Electric Co.2003-02-11
CARDIUS-1 AND CARDIS-2 (K030085)Digirad Corp.2003-02-05
GE DISCOVERY LS SYSTEM (K023988)GE Medical Systems2003-02-04
GE PHOTON ENERGY RECOVERY (PER) OPTION (K023932)Ge Medical Systems F.I. Haifa2002-12-11
ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 16 (K023768)Cti Pet Systems, Inc.2002-11-25
CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005 (K023110)Digirad Corp.2002-11-22
ECAT LSO PET/CT 16 (K023518)Cti Pet Systems, Inc.2002-11-08
GE QUASAR NUCLEAR MEDICINE SYSTEM (K022960)Ge Medical Systems F.I. Haifa2002-09-19
GE ROAD WARRIOR PET CT IMAGING SYSTEM (K022872)General Electric Co.2002-09-12
ECAT VISION PET SCANNER, MODELS 3000 & 5000 (K021633)Cti Pet Systems, Inc.2002-08-14
MOBILE MILLENNIUM MG SYSTEM (K022240)Ge Medical Systems, Inc.2002-08-06
MPOWER, MODEL 712 SERIES (K022001)Positron Corp.2002-07-12
CARDIOSPECT D90/CARDIO CAM (K021823)Nuclear Cardiology Systems, Inc.2002-06-17
HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4 (K021656)Nuclear Diagnostics2002-06-13
NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS) (K020300)Syntermed, Inc.2002-04-23
NEUROSPECTQUAD GAMMA CAMERA (K013353)Nuclear Cardiology Systems, Inc.2002-03-04
EMORY CARDIAC TOOLBOX 2.1 EXECUTING ON NUCLEAR MEDICINE COMPUTERS (K014033)Syntermed, Inc.2002-02-22
BCC GAMMA CAMERA (K013667)Is2 Research, Inc.2002-01-28
MODIFICATION TO SKYLIGHT IMAGING SYSTEM (K013496)Adac Laboratories2001-11-06
MODIFICATION TO: ECAT LSO PET/CT SCANNER (K013504)Cti Pet Systems, Inc.2001-10-31
GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER (K012775)GE Medical Systems2001-09-18
GE VISION NUCLEAR MEDICINE WORKSTATION (K012568)General Electric Co.2001-09-06
QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS) (K011572)Digirad Corp.2001-06-15
CARDIOCAM MODEL 9CSY0799 (K011611)Danish Diagnostic Development A/S2001-06-08
CEDARS-SINAI BPGS AND MOCO (K010509)Smv America2001-04-27
NUCAMMA BI90 (K003882)Is2 Research, Inc.2001-02-21
ORBITER II CCI/SPECT ORBITER II CCI/SPECT (K010137)Siemens Medical Solutions USA, Inc.2001-02-13
QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT) (K003358)Smv America2001-01-19
GE ADVANCE NXI PET SYSTEM (K003849)Ge Medical Systems, Inc.2000-12-22
QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION (K003264)Ge Medical Systems F.I. Haifa2000-12-21
ECAT PET SCANNER (K003241)Cti Pet Systems, Inc.2000-12-13
ALLEGRO TB, ALLEGRO N (K003434)Adac Laboratories2000-11-16
ECAT ACCEL PET SCANNER (K002584)Cti Pet Systems, Inc.2000-11-16
ECAT PET SCANNER (K002715)Cti Pet Systems, Inc.2000-10-31
WACKERS-LIU CQ SOFTWARE (K002229)Eclipse Systems, Inc.2000-10-20
DS DS I-SERIES (K002553)Smv America2000-09-15
POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM (K001681)Smv America2000-08-25
MEDICAL IMAGE MERGE (MIM) (K001276)Syntermed, Inc.2000-07-17
UNICORN MODEL SYS0630 (K001888)Danish Diagnostic Development A/S2000-06-30
3D-MSPECT (K001026)The Reagents of the University of Michigan2000-06-20
SKYLIGHT IMAGING SYSTEM (K000908)Adac Laboratories2000-04-05
CODE AC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA WITH COINCIDENCE OPTION (CODE) (K994167)Ge Medical Systems F.I. Haifa2000-03-07
MEDX INTECAM INTERFACE (K993893)Medx, Inc.2000-02-10
AUTOMATIC IMAGE REGISTRATION SOFTWARE, MODEL NSFU-050A (K992992)Toshiba America Medical Systems, In.C1999-12-03
E.CAM COMPUTER (K992731)Siemens Medical Solutions USA, Inc.1999-11-10
MAPS 10000 (K992560)Web Link Medical1999-10-29
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