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 |
|---|---|---|---|
| Sep 3, 2010 | K101550 | BIOGRAPH MCT FAMILY Siemens Medical Solutions USA, Inc. | KPS |
| Jun 7, 2010 | K101013 | MODIFICATION TO SCINTRON IV Miegmbh | KPS |
| Dec 10, 2009 | K093514 | DISCOVERY MODEL NM/CT 670 Ge Medical Systems F.I. Haifa, IL | KPS |
| Aug 27, 2009 | K090811 | INSPIRA HD, MODEL: NL1000 Neurologica Corporation | KPS |
| May 14, 2009 | K091073 | WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS Ultraspect , Ltd., IL | KPS |
| May 8, 2009 | K091269 | NEUROPET Photodetection Systems, Inc. | KPS |
| Apr 24, 2009 | K090178 | ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8 Neusoft Positron Medical Systems Co., Ltd., CN | KPS |
| Mar 31, 2009 | K090553 | NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER Naviscan, Inc. | KPS |
| Mar 31, 2009 | K090403 | AUTOSPECT Philips Medical Systems (Cleveland), Inc. | KPS |
| Mar 23, 2009 | K083852 | BIOGRAPH 16 TRUE POINT SYSTEMS Siemens Medical Solutions USA, Inc. | KPS |
| Mar 9, 2009 | K083649 | CARDIUS 3 X-ACT Digirad Corp. | KPS |
| Dec 17, 2008 | K082904 | STASYS MOTION CORRECTION SOFTWARE Digirad Corp. | KPS |
| Dec 12, 2008 | K083504 | GE DISCOVERY NM/CT 570C Ge Medical Systems F.I. Haifa, IL | KPS |
| Nov 21, 2008 | K082506 | SYMBIA, VERSION 4.0 Siemens Medical Solutions USA, Inc. | KPS |
| Nov 18, 2008 | K082354 | STEREO NAVIGATOR ACCESSORY, STN-1000 Naviscan Pet Systems | KPS |
| Nov 14, 2008 | K082581 | C-QUEST Medx, Inc. | KPS |
| Sep 12, 2008 | K082368 | CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT IMAGING SYSTEM Digirad Corp. | KPS |
| Aug 21, 2008 | K082244 | PCA-8000A, MARK 11, PET / CT SYSTEM Toshiba America Medical Systems, In.C | KPS |
| Jun 23, 2008 | K081453 | BIOGRAPH HD FAMILY Siemens Medical Solutions USA, Inc. | KPS |
| Jun 12, 2008 | K081496 | OPTIMA PET/CT 560 Ge Medical Systems, LLC | KPS |
| Jun 4, 2008 | K081426 | NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE Philips Medical Systems (Cleveland), Inc. | KPS |
| May 28, 2008 | K081201 | WBR XPRESS3.CARDIAC Ultraspect , Ltd., IL | KPS |
| May 13, 2008 | K080575 | CORRIDOR4DM Invia | KPS |
| Apr 29, 2008 | K081135 | GEMINI CONDOR Philips Medical Systems (Cleveland), Inc. | KPS |
| Apr 11, 2008 | K080927 | BRIGHTVIEW VCT IMAGING SYSTEM Philips Medical Systems (Cleveland), Inc. | KPS |
| Apr 2, 2008 | K080784 | WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE Ultraspect , Ltd., IL | KPS |
| Mar 14, 2008 | K072307 | QUANTITATIVE NEUROQ 3.0 Syntermed, Inc. | KPS |
| Jan 31, 2008 | K080124 | VENTRI 1.1 Ge Medical Systems F.I. Haifa, IL | KPS |
| Nov 6, 2007 | K073021 | MULTI-SPECT Eagle Heart Imaging, LLC | KPS |
| Oct 30, 2007 | K072567 | SYMBIA-E, MODEL 10275879 Siemens Medical Solutions USA, Inc. | KPS |
| Oct 25, 2007 | K072191 | CLEARVISION NUCLEAR MEDICINE IMAGING SYSTEM Gvi Technology Partners | KPS |
| Oct 1, 2007 | K072468 | MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM Spectrum Dynamics , Ltd., IL | KPS |
| Jul 26, 2007 | K071503 | SYSTEM, TOMOGRAPHY, COMPUTED EMISSION Syntermed, Inc. | KPS |
| May 14, 2007 | K071068 | BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197 Siemens Medical Solutions USA, Inc. | KPS |
| Apr 24, 2007 | K070589 | C! Transphoton Corporation | KPS |
| Mar 23, 2007 | K070542 | CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS Digirad Corp. | KPS |
| Oct 20, 2006 | K062450 | D-SPECT CARDIAC SCANNER SYSTEM Spectrum Dynamics , Ltd., IL | KPS |
| Sep 1, 2006 | K062393 | GE VANTAGE PET NEURO SOFTWARE GE Healthcare | KPS |
| Aug 23, 2006 | K062298 | APOLLO GAMMA CAMERA SYSTEM Adac Laboratories | KPS |
| Jun 30, 2006 | K061545 | SCENIUM 1.1 Siemens Molecular Imaging, Ltd. | KPS |
| Jun 23, 2006 | K061587 | FULLCARD ANALYSIS GE Healthcare | KPS |
| Mar 23, 2006 | K060486 | CYCLONE, MODEL MAICAM 180 Spectrica, CA | KPS |
| Mar 17, 2006 | K060631 | BIOGRAPH 64 AND BIOGRAPH 40 Siemens Medical Solutions USA, Inc. | KPS |
| Feb 3, 2006 | K060060 | BIOGRAPH 6 Siemens Medical Solutions USA, Inc. | KPS |
| Jan 27, 2006 | K053086 | MIE - GAMMA CAMERA SYSTEMS Mie America, Inc. | KPS |
| Jan 20, 2006 | K060020 | AUTOQUANT PLUS Adac Laboratories | KPS |
| Jan 6, 2006 | K053062 | CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2 Cardiarc , Ltd. | KPS |
| Oct 7, 2005 | K052640 | GEMINI RAPTOR Philips Medical Systems (Cleveland), Inc. | KPS |
| Oct 4, 2005 | K052430 | CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM Digirad Corp. | KPS |
| Sep 27, 2005 | K052434 | HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA GE Medical Systems, IL | KPS |
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