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
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2009 | GE Medical Systems, LLC GE Healthcare, Infinia, Model Numbers:
ASM000886
ASM001391
ASM001333
ASM001465
ASM001473
ASM001620
ASM500016
H3000WM
H3000WT
H3000WY and
SYS000041.
The device is used to perform general Nu Terminated |
KPS | K022960 |
| Jan 16, 2009 | Philips Medical Systems (Cleveland) Inc Vertical drive brake (on patient supports). Used on certain Philips Medical Systems MX series and Brilliance series CT scanners.
The device is a vertical drive brake that controls the vertical posi Terminated |
KPS | K010817 K012009 +2 |
| Oct 28, 2008 | Philips Medical Systems (Cleveland) Inc Respiratory Gating System which includes: Pulmonary Digital Assembly Kit and Pulmonary Toolkit Oncology Pro, Model #455011203131 and Model #455011203191. Terminated |
KPS | K012009 K033326 +1 |
| Oct 27, 2008 | Siemens Medical Solutions USA, Inc. Symbia T16 System; a dual-detector variable angle gamma camera with a sixteen slice CT scanner; Siemens Medical Solutions USA, Inc., Molecular imaging, Hoffman Estates, IL 60192. The system is used t Terminated |
KPS | K041166 |
| Oct 27, 2008 | Siemens Medical Solutions USA, Inc. Symbia T6 System; a dual-detector variable angle gamma camera with a six slice CT scanner; Siemens Medical Solutions USA, Inc., Molecular imaging, Hoffman Estates, IL 60192. The system is used to per Terminated |
KPS | K041166 |
| Sep 19, 2008 | Philips Medical Systems (Cleveland) Inc Rotate Motion Shunt Resistor Kit, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143 Terminated |
KPS | K964712 |
| Sep 19, 2008 | Philips Medical Systems (Cleveland) Inc Irix Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143 Terminated |
KPS | K964712 |
| Sep 19, 2008 | Philips Medical Systems (Cleveland) Inc Axis Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143 Terminated |
KPS | K964712 |
| Sep 11, 2008 | Naviscan PET Systems Naviscan PET Systems, Inc ("Naviscan") PEM Flex Solo II PET Scanner. The PEM Flex Solo II images small body parts with optimized PET technology. Terminated |
KPS | K032063 |
| Sep 5, 2008 | GE Healthcare DST-XL Model 1002375 is a multi-head, whole body gamma camera with infrared body contouring and anti-collision computed tomography system. Terminated |
KPS | K942837 |
| Feb 8, 2008 | Phillips Nuclear Medicine Philips Medical Systems -- Cardiac Viewer or Pulmonary Viewer software application version 2.0 in use with Precedence SPECT/CT System and all CT EBW workstations using software version 3.5. Philips N Terminated |
KPS | K041218 |
| Jan 31, 2008 | Philips Medical Systems (Cleveland) Inc Philips Medical Systems, GEMINI GXL 6, 10, & 16 slice PET/CT Systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Terminated |
KPS | K051170 K052640 |
| Jan 31, 2008 | Philips Medical Systems (Cleveland) Inc Philips Medical Systems, GEMINI TF 16 & 64 slice PET/CT Systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomog Terminated |
KPS | K051170 K052640 |
| Jan 4, 2008 | Siemens Medical Solutions USA Inc Biograph DUO LSO, Biograph PET/CT Scanner, Catalog No. 8728813, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | K002584 K003541 +2 |
| Jan 4, 2008 | Siemens Medical Solutions USA Inc Biograph 64-3 Ring, Biograph PET/CT Scanner, Catalog No. 8727450, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | K002584 K003541 +2 |
| Jan 4, 2008 | Siemens Medical Solutions USA Inc Biograph 6, Biograph PET/CT Scanner, Catalog No. 8728573, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | K002584 K003541 +2 |
| Jan 4, 2008 | Siemens Medical Solutions USA Inc Biograph 6, Biograph PET/CT Scanner, Catalog No. 8728854, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | K002584 K003541 +2 |
| Jan 4, 2008 | Siemens Medical Solutions USA Inc Biograph 40 TruePoint, Biograph PET/CT Scanner, Catalog No. 10097303, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | K002584 K003541 +2 |
| Jan 4, 2008 | Siemens Medical Solutions USA Inc Biograph 40 - 3 Ring, Biograph PET/CT Scanner, Catalog No. 10097233, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | K002584 K003541 +2 |
| Jan 4, 2008 | Siemens Medical Solutions USA Inc Biograph 16, Biograph PET/CT Scanner, Catalog No. 872858, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | K002584 K003541 +2 |
| Dec 19, 2007 | Siemens Medical Solutions USA, Inc. c.cam Gamma Camera, Model No: 9VIR1200; Tomography System (Emission Computed); Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, IL 60195-5203; Made in Terminated |
KPS | K031825 |
| Nov 29, 2007 | Siemens Medical Solutions USA Inc Siemens ECAT EXACT HR+, Catalog No. 3548083, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | K002584 K003541 +2 |
| Nov 29, 2007 | Siemens Medical Solutions USA Inc Siemens ECAT EXACT HR 47, Catalog No. 2956261, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | K002584 K003541 +2 |
| Nov 29, 2007 | Siemens Medical Solutions USA Inc Siemens ECAT EXACT 47, Catalog No. 1788772, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | K002584 K003541 +2 |
| Nov 29, 2007 | Siemens Medical Solutions USA Inc Siemens ECAT ART, Catalog No.. 3545584, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | K002584 K003541 +2 |
| Nov 29, 2007 | Siemens Medical Solutions USA Inc Siemens ECAT ACCEL, Catalog No. 3554479, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | K002584 K003541 +2 |
| Oct 11, 2007 | Naviscan PET Systems PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner, for nuclear medicine imaging. Terminated |
KPS | K032063 |
| Sep 26, 2007 | Philips Medical Systems (Cleveland) Inc Brilliance(a) CT 6 slice, Model #4535 670 73191.
Brilliance(a) CT 10 Slice, Model 4535 670 73181.
Brilliance 16 Slice, Model #4535 670 78851.
Brilliance CT 16 Power, Model #4535 670 23331.
Bri Terminated |
KPS | K010817 K033326 +1 |
| Sep 26, 2007 | Philips Medical Systems (Cleveland) Inc Nuclear medicine systems:
Gemini 16, Model 4535 679 28961.
Gemini GXL, Models # 4535 679 71891, #4535 679 75681, #4535 679 75691.
Precedence, Model #2169 -3000A, #2169-3001A, #2169-3002A, and Terminated |
KPS | K041955 K042935 |
| Jun 6, 2007 | Siemens Medical Solutions USA, Inc. c.cam Gamma Camera, Model 9VIR1200; Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, IL 60195-5203; Made in Denmark; Terminated |
KPS | K031825 |
| Feb 23, 2007 | Siemens Medical Solutions USA, Inc. Symbia S Series SPECT (Single-Photon Emission Computed Tomography) System with a Pinhole Collimator; Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, I Terminated |
KPS | K041166 |
| Nov 16, 2006 | Trionix Research Laboratory Inc BIAD Classic 24 (24 inch collimator). The collimator is a component of the Trionix Biad Full Imaging System. Terminated |
KPS | K892875 |
| Jun 2, 2006 | General Electric Med Systems LLC Discovery ST PET/CT imaging system with gantry model number 5105797. Catalog Identifiers: S9114LA/LB/MA/MN, S9118LA/LB/MA/MN, S9116LA/MA. The system combines the high performance Lightspeed Plus CT Terminated |
KPS | K042257 |
| Apr 4, 2006 | Siemens Medical Solutions USA Inc ECAT Emerge PET Scanners (distributed by Siemens Medical Solutions USA, Inc.), ECAT ART PET Scanners (distributed by Siemens Medical Solutions USA, Inc.) and Sceptre PET Scanners (distributed by Hitac Terminated |
KPS | K003241 K940478 |
| Jan 24, 2006 | GE Healthcare GE Millennium Systems: MPR and MPS Digital CSE Single Detector Gamma Camera. This system is a multi-purpose single-head nuclear medicine imaging system, comprised of a Digital CSE (Correlated Signal Terminated |
KPS | K962738 |
| Jan 24, 2006 | GE Healthcare GE Millennium Systems: MG. Multi-Geometry Digital CSE Dual Detector Gamma Camera. A modular nuclear medicine imaging system. The MG gantry allows the detectors to be oriented in the 180-degree and Terminated |
KPS | K962738 |
| Jan 24, 2006 | GE Healthcare GE Millennium Systems: MC, MyoSight. Dual Head Gamma Camera. A compact cardiac-optimized nuclear imaging system. It is comprised of 2 digital CSE (Correlated Signal Enhancement) detectors in varia Terminated |
KPS | K962738 |
| Oct 28, 2005 | General Electric Med Systems LLC Sopha Medical Vision DST / DST-XL Digital vatiable angle Nuclear Imaging System Terminated |
KPS | K942837 |
| May 11, 2005 | CTI PET Systems Inc ECAT PET Scanners (mobile systems), distributed by Siemens Medical Solutions
ECAT PET Scanners (mobile systems), and Reveal XL (mobile systems), distributed by CTI Molecular Imagining, Inc.
Sceptre an Terminated |
KPS | K002584 K003241 +1 |
| Apr 6, 2005 | Philips Medical Systems Sales & Service Region No. America Tomoscan Terminated |
KPS | None listed |
| Feb 16, 2005 | CTI PET Systems Inc PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography) and X-Ray Computed Tomography (CT) systems:
Siemens Models: Biograph PET/CT
CTI Models: Reveal Terminated |
KPS | K002715 K013504 +3 |
| Oct 7, 2004 | General Electric Med Systems LLC Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam. Terminated |
KPS | K953801 |
| Jul 20, 2004 | Adac Labs Emission Computed Tomography System Terminated |
KPS | K011611 |
| Jul 20, 2004 | Toshiba American Med Sys Inc Pinhole Collimator (NDCL709A) for Digital Gamma Cameras GCA-7100A series and CGA-7200A series.
Regulation Number 21 CFR 892.1200, Class 2 device, . Terminated |
KPS | K931297 |
| Nov 13, 2003 | Cti Pet Systems Inc Siemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT Terminated |
KPS | K002715 K013504 |
| Oct 24, 2003 | Siemens Medical Solutions USA, Inc. e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203 Terminated |
KPS | K952109 |
| May 16, 2003 | Siemens Medical Solutions USA, Inc Somatom Sensation 16, Computed Tomography System, Diagnostic Imaging. Terminated |
KPS | K013522 |
| Mar 21, 2003 | Cti Pet Systems Inc ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET (Positron Emission Tomography) systems:
Siemens Models: ECAT EXACT, ECAT EXACT HR, ECAT EXACT HR+, ECAT ART, ECA Terminated |
KPS | K002584 K913637 +3 |
| Mar 6, 2003 | Siemens Medical Solutions USA, Inc. e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc.,
Nuclear Medicine Group, Hoffman Estates, IL 60195-5203 Terminated |
KPS | K952109 |
| Feb 21, 2003 | Philips Medical Systems Inc Prism 3000S and 3000XP Gamma Camera Systems, Models N210060 and N210335. Terminated |
KPS | K882312 |
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