ClearanceBrief
Panels › Radiology › Product code KPS · Class 2

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)
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Top companies in KPS

DateFirm and productCodeLinked 510(k)
Apr 10, 2009GE 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
KPSK022960
Jan 16, 2009Philips 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
KPSK010817
K012009 +2
Oct 28, 2008Philips Medical Systems (Cleveland) Inc
Respiratory Gating System which includes: Pulmonary Digital Assembly Kit and Pulmonary Toolkit Oncology Pro, Model #455011203131 and Model #455011203191.
Terminated
KPSK012009
K033326 +1
Oct 27, 2008Siemens 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
KPSK041166
Oct 27, 2008Siemens 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
KPSK041166
Sep 19, 2008Philips Medical Systems (Cleveland) Inc
Rotate Motion Shunt Resistor Kit, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143
Terminated
KPSK964712
Sep 19, 2008Philips Medical Systems (Cleveland) Inc
Irix Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143
Terminated
KPSK964712
Sep 19, 2008Philips Medical Systems (Cleveland) Inc
Axis Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143
Terminated
KPSK964712
Sep 11, 2008Naviscan 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
KPSK032063
Sep 5, 2008GE Healthcare
DST-XL Model 1002375 is a multi-head, whole body gamma camera with infrared body contouring and anti-collision computed tomography system.
Terminated
KPSK942837
Feb 8, 2008Phillips 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
KPSK041218
Jan 31, 2008Philips 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
KPSK051170
K052640
Jan 31, 2008Philips 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
KPSK051170
K052640
Jan 4, 2008Siemens 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
KPSK002584
K003541 +2
Jan 4, 2008Siemens 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
KPSK002584
K003541 +2
Jan 4, 2008Siemens 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
KPSK002584
K003541 +2
Jan 4, 2008Siemens 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
KPSK002584
K003541 +2
Jan 4, 2008Siemens 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
KPSK002584
K003541 +2
Jan 4, 2008Siemens 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
KPSK002584
K003541 +2
Jan 4, 2008Siemens 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
KPSK002584
K003541 +2
Dec 19, 2007Siemens 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
KPSK031825
Nov 29, 2007Siemens 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
KPSK002584
K003541 +2
Nov 29, 2007Siemens 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
KPSK002584
K003541 +2
Nov 29, 2007Siemens 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
KPSK002584
K003541 +2
Nov 29, 2007Siemens 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
KPSK002584
K003541 +2
Nov 29, 2007Siemens 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
KPSK002584
K003541 +2
Oct 11, 2007Naviscan PET Systems
PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner, for nuclear medicine imaging.
Terminated
KPSK032063
Sep 26, 2007Philips 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
KPSK010817
K033326 +1
Sep 26, 2007Philips 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
KPSK041955
K042935
Jun 6, 2007Siemens 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
KPSK031825
Feb 23, 2007Siemens 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
KPSK041166
Nov 16, 2006Trionix Research Laboratory Inc
BIAD Classic 24 (24 inch collimator). The collimator is a component of the Trionix Biad Full Imaging System.
Terminated
KPSK892875
Jun 2, 2006General 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
KPSK042257
Apr 4, 2006Siemens 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
KPSK003241
K940478
Jan 24, 2006GE 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
KPSK962738
Jan 24, 2006GE 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
KPSK962738
Jan 24, 2006GE 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
KPSK962738
Oct 28, 2005General Electric Med Systems LLC
Sopha Medical Vision DST / DST-XL Digital vatiable angle Nuclear Imaging System
Terminated
KPSK942837
May 11, 2005CTI 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
KPSK002584
K003241 +1
Apr 6, 2005Philips Medical Systems Sales & Service Region No. America
Tomoscan
Terminated
KPSNone listed
Feb 16, 2005CTI 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
KPSK002715
K013504 +3
Oct 7, 2004General Electric Med Systems LLC
Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam.
Terminated
KPSK953801
Jul 20, 2004Adac Labs
Emission Computed Tomography System
Terminated
KPSK011611
Jul 20, 2004Toshiba 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
KPSK931297
Nov 13, 2003Cti Pet Systems Inc
Siemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT
Terminated
KPSK002715
K013504
Oct 24, 2003Siemens 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
KPSK952109
May 16, 2003Siemens Medical Solutions USA, Inc
Somatom Sensation 16, Computed Tomography System, Diagnostic Imaging.
Terminated
KPSK013522
Mar 21, 2003Cti 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
KPSK002584
K913637 +3
Mar 6, 2003Siemens 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
KPSK952109
Feb 21, 2003Philips Medical Systems Inc
Prism 3000S and 3000XP Gamma Camera Systems, Models N210060 and N210335.
Terminated
KPSK882312

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