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 |
|---|---|---|---|
| Nov 4, 2016 | K161740 | D-SPECT Scanner, D-SPECT L Scanner Spectrum Dynamics Medical, Ltd., IL | KPS |
| Oct 25, 2016 | K162736 | Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT Siemens Medical Solutions USA, Inc. | KPS |
| Oct 20, 2016 | K161674 | QuantumCam Ddd-Diagnostic A/S, DK | KPS |
| Sep 8, 2016 | K162337 | Symbia 6.5 Siemens Medical Solutions USA, Inc. | KPS |
| Aug 11, 2016 | K161574 | Discovery MI Ge Medical Systems, LLC | KPS |
| Jul 28, 2016 | K161631 | MAMMI General Equipment For Medical Imaging, ES | KPS |
| Jun 1, 2016 | K153056 | Hermes Medical Imaging Suite v5.6 Hermes Medical Solutions AB, SE | KPS |
| Mar 21, 2016 | K160120 | D-SPECT Processing and Reviewing Workstation Spectrum Dynamics , Ltd., IL | KPS |
| Jan 25, 2016 | K152503 | ImagenSPECT Cardiovascular Imaging Technologies | KPS |
| Jan 21, 2016 | K153402 | Discovery NM/CT 670 CZT GE Healthcare, IL | KPS |
| Jan 12, 2016 | K152880 | Biograph Horizon PET/CT Siemens Medical Solutions USA, Inc. | KPS |
| Nov 2, 2015 | K151403 | Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Neusoft Medical Systems Co., Ltd., CN | KPS |
| Jul 17, 2015 | K151486 | Biograph mCT and mCT Flow PET/CT Scanners Siemens Medical Solutions USA, Inc. | KPS |
| Apr 14, 2015 | K143664 | HeartSee University of Texas Medical School AT Houston | KPS |
| Dec 18, 2014 | K142631 | Hermes Medical Imaging Suite v5.5 Hermes Medical Solutions AB, SE | KPS |
| Sep 18, 2014 | K141477 | DISCOVERY IQ Ge Medical Systems, LLC | KPS |
| Sep 18, 2014 | K141074 | CORTEX ID SUITE Ge Medical Systems, LLC | KPS |
| Sep 12, 2014 | K141971 | BIOGRAPH TRUE PET/CT FAMILY SOFTWARE Siemens Medical Solutions USA, Inc. | KPS |
| Aug 21, 2014 | K142006 | SYMBIA 6.0 Siemens Medical Solutions USA, Inc. | KPS |
| Jul 22, 2014 | K141652 | CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE Cedars-Sinai Medical Center | KPS |
| Jun 11, 2014 | K140996 | MAMMI General Equipment For Medical Imaging (Oncovision-, ES | KPS |
| Jun 11, 2014 | K140651 | CELESTEION, PCA-9000A/2 Toshibamedical Systems Corporation | KPS |
| May 8, 2014 | K140269 | HERMES MEDICAL IMAGING SUITE V5.4 Hermes Medical Solutions AB, SE | KPS |
| May 8, 2014 | K140206 | SCINTILLATION GAMMA CAMERA Ddd-Diagnostic A/S, DK | KPS |
| Mar 21, 2014 | K133657 | DISCOVERY PET/CT 710 Ge Medical Systems, LLC | KPS |
| Nov 20, 2013 | K132347 | MULTICAM 3000 ECO Inter Medical Medizintechnik GmbH | KPS |
| Oct 3, 2013 | K131625 | ANYSCAN-S SPECT IMAGING SYSTEM Absolute Imaging Solutions | KPS |
| Aug 16, 2013 | K131634 | SYMBIA Siemens Medical Solutions USA, Inc. | KPS |
| Jul 16, 2013 | K131233 | HERMES MEDICAL IMAGING SUITE V5.3 Hermes Medical Solutions AB, SE | KPS |
| Jul 12, 2013 | K123599 | INGENUITY DIGITAL PET/CT Philips Healthcare (Cleveland) | KPS |
| Jun 14, 2013 | K130902 | EMORY CARDIAC TOOLBOX 3.2 Syntermed, Inc. | KPS |
| May 17, 2013 | K130451 | NEUROQ 3.6 Syntermed, Inc. | KPS |
| Apr 19, 2013 | K130269 | ECAT SCINTRON PET Miegmbh, DE | KPS |
| Feb 26, 2013 | K123433 | CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE Cedars-Sinai Medical Center | KPS |
| Feb 22, 2013 | K123646 | EMORY CARDIAC TOOLBOX 4.0 Syntermed, Inc. | KPS |
| Jan 29, 2013 | K123737 | BIOGRAPH MCT FAMILY Siemens Medical Solutions USA, Inc. | KPS |
| Dec 18, 2012 | K121278 | HERMES MEDICAL IMAGING SUITE V5.2 Hermes Medical Solutions AB, SE | KPS |
| Oct 24, 2012 | K122241 | IMAGEN3D Cardiovascular Imaging Technologies | KPS |
| Jul 19, 2012 | K113754 | CFR QUANT University of Texas Medical School AT Houston | KPS |
| Apr 19, 2012 | K121019 | OPTIMA NM/CT 640 GE Healthcare, IL | KPS |
| Feb 24, 2012 | K113408 | Q. FREEZE (MOTION VUE2) Ge Medical Systems, LLC | KPS |
| Jan 13, 2012 | K113086 | ACQA Texas Medical Imaging Consultants | KPS |
| Dec 17, 2011 | K113448 | BIOGRAPH MCT FAMILY Siemens Medical Solutions USA, Inc. | KPS |
| Dec 5, 2011 | K113350 | BRIVO NM 615 GE Healthcare, IL | KPS |
| Sep 23, 2011 | K112474 | CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE Cedars-Sinai Medical Center | KPS |
| Jul 13, 2011 | K110507 | CARDIAC SCANNER AND PROCESSING SYSTEM Spectrum Dynamics (Israel) , Ltd., IL | KPS |
| Jun 3, 2011 | K111445 | DISCOVERY NM 630 GE Healthcare, IL | KPS |
| Apr 1, 2011 | K100714 | CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01 Cedars-Sinai Medical Center | KPS |
| Jan 19, 2011 | K103710 | WBR XPRESS PET Ultraspect , Ltd., IL | KPS |
| Oct 5, 2010 | K101768 | MIE SCINTRON GAMMA CAMERA SYSTEMS Miegmbh, DE | KPS |
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