System, Tomography, Computed, Emission
Regulation 892.1200
9510(k)s in 12 months (473 all time)
9recalls in 12 months (450 all time)
435recalls that name a 510(k)
Top companies in KPS
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 11, 2003 | K032036 | GEMINI 16 Philips Medical Systems (Cleveland), Inc. | KPS |
| Jun 20, 2003 | K031872 | ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC IMAGING] Adac Laboratories | KPS |
| Jun 20, 2003 | K031825 | C.CAM Danish Diagnostic Development A/S, DK | KPS |
| Jun 17, 2003 | K031705 | SKYLIGHT IMAGING SYSTEM Adac Laboratories | KPS |
| Apr 9, 2003 | K030870 | WBR, MODEL HR U.C.G. Technologies , Ltd., IL | KPS |
| Feb 11, 2003 | K030199 | GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM General Electric Co. | KPS |
| Feb 5, 2003 | K030085 | CARDIUS-1 AND CARDIS-2 Digirad Corp. | KPS |
| Feb 4, 2003 | K023988 | GE DISCOVERY LS SYSTEM GE Medical Systems | KPS |
| Dec 11, 2002 | K023932 | GE PHOTON ENERGY RECOVERY (PER) OPTION Ge Medical Systems F.I. Haifa, IL | KPS |
| Nov 25, 2002 | K023768 | ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 16 Cti Pet Systems, Inc. | KPS |
| Nov 22, 2002 | K023110 | CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005 Digirad Corp. | KPS |
| Nov 8, 2002 | K023518 | ECAT LSO PET/CT 16 Cti Pet Systems, Inc. | KPS |
| Sep 19, 2002 | K022960 | GE QUASAR NUCLEAR MEDICINE SYSTEM Ge Medical Systems F.I. Haifa, IL | KPS |
| Sep 12, 2002 | K022872 | GE ROAD WARRIOR PET CT IMAGING SYSTEM General Electric Co. | KPS |
| Aug 14, 2002 | K021633 | ECAT VISION PET SCANNER, MODELS 3000 & 5000 Cti Pet Systems, Inc. | KPS |
| Aug 6, 2002 | K022240 | MOBILE MILLENNIUM MG SYSTEM Ge Medical Systems, Inc. | KPS |
| Jul 12, 2002 | K022001 | MPOWER, MODEL 712 SERIES Positron Corp. | KPS |
| Jun 17, 2002 | K021823 | CARDIOSPECT D90/CARDIO CAM Nuclear Cardiology Systems, Inc. | KPS |
| Jun 13, 2002 | K021656 | HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4 Nuclear Diagnostics, SE | KPS |
| Apr 23, 2002 | K020300 | NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS) Syntermed, Inc. | KPS |
| Mar 4, 2002 | K013353 | NEUROSPECTQUAD GAMMA CAMERA Nuclear Cardiology Systems, Inc. | KPS |
| Feb 22, 2002 | K014033 | EMORY CARDIAC TOOLBOX 2.1 EXECUTING ON NUCLEAR MEDICINE COMPUTERS Syntermed, Inc. | KPS |
| Jan 28, 2002 | K013667 | BCC GAMMA CAMERA Is2 Research, Inc., CA | KPS |
| Nov 6, 2001 | K013496 | MODIFICATION TO SKYLIGHT IMAGING SYSTEM Adac Laboratories | KPS |
| Oct 31, 2001 | K013504 | MODIFICATION TO: ECAT LSO PET/CT SCANNER Cti Pet Systems, Inc. | KPS |
| Sep 18, 2001 | K012775 | GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER GE Medical Systems | KPS |
| Sep 6, 2001 | K012568 | GE VISION NUCLEAR MEDICINE WORKSTATION General Electric Co. | KPS |
| Jun 15, 2001 | K011572 | QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS) Digirad Corp. | KPS |
| Jun 8, 2001 | K011611 | CARDIOCAM MODEL 9CSY0799 Danish Diagnostic Development A/S, DK | KPS |
| Apr 27, 2001 | K010509 | CEDARS-SINAI BPGS AND MOCO Smv America | KPS |
| Feb 21, 2001 | K003882 | NUCAMMA BI90 Is2 Research, Inc., CA | KPS |
| Feb 13, 2001 | K010137 | ORBITER II CCI/SPECT ORBITER II CCI/SPECT Siemens Medical Solutions USA, Inc. | KPS |
| Jan 19, 2001 | K003358 | QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT) Smv America | KPS |
| Dec 22, 2000 | K003849 | GE ADVANCE NXI PET SYSTEM Ge Medical Systems, Inc. | KPS |
| Dec 21, 2000 | K003264 | QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION Ge Medical Systems F.I. Haifa, IL | KPS |
| Dec 13, 2000 | K003241 | ECAT PET SCANNER Cti Pet Systems, Inc. | KPS |
| Nov 16, 2000 | K003434 | ALLEGRO TB, ALLEGRO N Adac Laboratories | KPS |
| Nov 16, 2000 | K002584 | ECAT ACCEL PET SCANNER Cti Pet Systems, Inc. | KPS |
| Oct 31, 2000 | K002715 | ECAT PET SCANNER Cti Pet Systems, Inc. | KPS |
| Oct 20, 2000 | K002229 | WACKERS-LIU CQ SOFTWARE Eclipse Systems, Inc. | KPS |
| Sep 15, 2000 | K002553 | DS DS I-SERIES Smv America | KPS |
| Aug 25, 2000 | K001681 | POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM Smv America | KPS |
| Jul 17, 2000 | K001276 | MEDICAL IMAGE MERGE (MIM) Syntermed, Inc. | KPS |
| Jun 30, 2000 | K001888 | UNICORN MODEL SYS0630 Danish Diagnostic Development A/S, DK | KPS |
| Jun 20, 2000 | K001026 | 3D-MSPECT The Reagents of the University of Michigan | KPS |
| Apr 5, 2000 | K000908 | SKYLIGHT IMAGING SYSTEM Adac Laboratories | KPS |
| Mar 7, 2000 | K994167 | CODE AC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA WITH COINCIDENCE OPTION (CODE) Ge Medical Systems F.I. Haifa, IL | KPS |
| Feb 10, 2000 | K993893 | MEDX INTECAM INTERFACE Medx, Inc. | KPS |
| Dec 3, 1999 | K992992 | AUTOMATIC IMAGE REGISTRATION SOFTWARE, MODEL NSFU-050A Toshiba America Medical Systems, In.C | KPS |
| Nov 10, 1999 | K992731 | E.CAM COMPUTER Siemens Medical Solutions USA, Inc. | KPS |
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