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 |
|---|---|---|---|
| Aug 2, 2005 | K051855 | VENTRI Ge Medical Systems F.I. Haifa, IL | KPS |
| Jul 13, 2005 | K051549 | CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM Digirad Corp. | KPS |
| Jun 15, 2005 | K051460 | C.CAM-AC Danish Diagnostic Development A/S, DK | KPS |
| Jun 8, 2005 | K051351 | PRECEDENCE SPECT/CT IMAGING SYSTEM Adac Laboratories | KPS |
| May 23, 2005 | K051170 | GEMINI GXL Philips Medical Systems (Cleveland), Inc. | KPS |
| Apr 26, 2005 | K050815 | XACT.CARDIAC & XPRESS.CARDIAC Ultraspect , Ltd., IL | KPS |
| Mar 25, 2005 | K050509 | LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I Cti Pet Systems, Inc. | KPS |
| Mar 17, 2005 | K050559 | GE DISCOVERY VCT SYSTEM GE Medical Systems | KPS |
| Mar 17, 2005 | K050366 | IMAGENPRO Cardiovascular Imaging Technologies, LLC | KPS |
| Jan 13, 2005 | K043441 | MIRAGE, RELEASE 5.5 Segami Corporation | KPS |
| Dec 23, 2004 | K043381 | INFINIA LIGHTSPEED Ge Medical Systems F.I. Haifa, IL | KPS |
| Dec 17, 2004 | K043293 | MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U Acrorad Co., Ltd. | KPS |
| Dec 15, 2004 | K042863 | SCENIUM Siemens Molecular Imaging, Ltd. | KPS |
| Nov 9, 2004 | K042935 | GEMINI GXL Philips Medical Systems (Cleveland), Inc. | KPS |
| Nov 3, 2004 | K042880 | JETSTREAM WORKSPACE Adac Laboratories | KPS |
| Oct 29, 2004 | K042903 | AUTOSPECS Adac Laboratories | KPS |
| Oct 29, 2004 | K042839 | C-PET PLUS IMAGING SYSTEM Philips Medical Systems (Cleveland), Inc. | KPS |
| Oct 4, 2004 | K042258 | BP-SPECT V1.O Syntermed, Inc. | KPS |
| Oct 1, 2004 | K042467 | LSO PET/CT HIREZ 64 Cti Pet Systems, Inc. | KPS |
| Sep 17, 2004 | K042428 | SCEPTREP3 PET/CT Hitachi Medical Systems America, Inc. | KPS |
| Sep 8, 2004 | K042257 | DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION General Electric Co. | KPS |
| Aug 20, 2004 | K041840 | MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM Medx, Inc. | KPS |
| Jul 29, 2004 | K041955 | GEMINI PET/CT IMAGING SYSTEM Philips Medical Systems (Cleveland), Inc. | KPS |
| Jul 22, 2004 | K041671 | IMAGENMD Cardiovascular Imaging Technologies, LLC | KPS |
| Jun 22, 2004 | K041543 | GE DISCOVERY ST GE Healthcare | KPS |
| Jun 17, 2004 | K041022 | NEUROQ - PET DP Syntermed, Inc. | KPS |
| Jun 15, 2004 | K041220 | GE DISCOVERY ST SYSTEM GE Medical Systems | KPS |
| Jun 7, 2004 | K040933 | ECAT HRRT Cti Pet Systems, Inc. | KPS |
| May 24, 2004 | K041218 | GRIFFIN SPECT/CT IMAGING SYSTEM Adac Laboratories | KPS |
| May 21, 2004 | K041182 | SYNTEGRA Adac Laboratories | KPS |
| May 17, 2004 | K041166 | SIEMENS ENHANCED IMAGING SYSTEM Siemens Medical Solutions USA, Inc. | KPS |
| Apr 7, 2004 | K040172 | MODIFICATION TO GE DISCOVERY LS SYSTEM GE Medical Systems | KPS |
| Mar 24, 2004 | K040616 | CARDIOMD-AC Danish Diagnostic Development A/S, DK | KPS |
| Mar 11, 2004 | K040370 | WBR-FHR, WBR-FWB Ultraspect , Ltd., IL | KPS |
| Feb 25, 2004 | K040326 | AUTOQUANT PLUS Adac Laboratories | KPS |
| Feb 2, 2004 | K040057 | MOBILE COMPACT DIGITAL CARDIAC CAMERA Is2 Research, Inc., CA | KPS |
| Jan 30, 2004 | K040141 | EMORY CARDIAC TOOLBOX VERSION 2.6 Syntermed, Inc. | KPS |
| Jan 20, 2004 | K033956 | MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC) Is2 Research, Inc., CA | KPS |
| Dec 30, 2003 | K033874 | MYOLIGHT Ge Medical Systems F.I. Haifa, IL | KPS |
| Dec 24, 2003 | K033001 | APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4 Transphoton Corporation | KPS |
| Dec 19, 2003 | K033782 | ALLEGRO IMAGING SYSTEM Philips Medical Systems (Cleveland), Inc. | KPS |
| Dec 17, 2003 | K032779 | MODIFICATION TO: NUCAMMA RX Is2 Research, Inc., CA | KPS |
| Dec 12, 2003 | K033735 | VANTAGE PRO ATTENUATION CORRECTION DEVICE Adac Laboratories | KPS |
| Dec 12, 2003 | K032866 | CLARITY PET Shared P.E.T. Imaging, LLC | KPS |
| Nov 20, 2003 | K033431 | LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ Cti Pet Systems, Inc. | KPS |
| Nov 12, 2003 | K033199 | COMPACT DIGITAL CARDIAC CAMERA (CDCC) Is2 Medical Systems, Inc., CA | KPS |
| Oct 22, 2003 | K033254 | FORTE GAMMA CAMERA SYSTEM Adac Laboratories | KPS |
| Aug 25, 2003 | K032500 | MODIFICARION TO WACKERS-LIU CQ SOFTWARE Eclipse Systems, Inc. | KPS |
| Aug 18, 2003 | K032063 | PEM 2400 PET SCANNER Pem Technologies | KPS |
| Jul 18, 2003 | K031874 | MODIFICATION TO WBR, MODEL HR U.C.G. Technologies , Ltd., IL | KPS |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.