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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)
Jun 21, 2016Siemens Medical Solutions USA Inc.
BIOGRAPH 40 - 3 Ring, Material Number 10097233 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registrat
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
Biograph 16 TruePoint TV, Material Number 10249556 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide regis
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
Biograph mCT-X 4R, MATERIAL NUMBER 10248670 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registratio
Terminated
KPSK141971
Jun 15, 2016Siemens Medical Solutions USA Inc.
BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that prov
Terminated
KPSK123737
Jun 15, 2016Siemens Medical Solutions USA Inc.
BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that prov
Terminated
KPSK123737
Jun 15, 2016Siemens Medical Solutions USA Inc.
Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provid
Terminated
KPSK123737
Jun 15, 2016Siemens Medical Solutions USA Inc.
BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that prov
Terminated
KPSK123737
May 25, 2016Philips Medical Systems (Cleveland) Inc
BrightView XCT Upgrade Model 882454
Terminated
KPSK080927
May 25, 2016Philips Medical Systems (Cleveland) Inc
BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)
Terminated
KPSK080927
May 25, 2016Philips Medical Systems (Cleveland) Inc
BrightView X, model #882478; gamma camera designed for single or dual detector nuclear imaging
Terminated
KPSK062298
May 4, 2016Toshiba American Medical Systems Inc
Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acquire CT images, PET images, and fusion images (superimposed PET and CT images). Th
Terminated
KPSK140651
Mar 31, 2016Siemens Medical Solutions USA, Inc.
E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole b
Terminated
KPSK142006
Mar 4, 2016Philips Medical Systems (Cleveland) Inc
Extended Brilliance Workspace NM Special Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH. Provides software
Terminated
KPSK090403
Mar 4, 2016Philips Medical Systems (Cleveland) Inc
Extended Brilliance Workspace NM Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH. Provides software applica
Terminated
KPSK090403
Feb 26, 2016Siemens Medical Solutions USA, Inc.
The Symbia gamma camera system Product Usage: The Symbia gamma camera system is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce cross-sectional images of th
Terminated
KPSK142006
Feb 26, 2016Siemens Medical Solutions USA, Inc.
The E.CAM gamma camera system Product Usage: The E.CAM gamma camera system is a SPECT system and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various me
Terminated
KPSK142006
Feb 10, 2016GE Medical Systems, LLC
LightSpeed Plus (4-slice MDAS LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST syst
Terminated
KPSK040172
Feb 10, 2016GE Medical Systems, LLC
LightSpeed 16 (MDAS only , , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery
Terminated
KPSK081496
Feb 10, 2016GE Medical Systems, LLC
Discovery ST, , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - T
Terminated
KPSK040172
Feb 10, 2016GE Medical Systems, LLC
Discovery LS, 2286327 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - Th
Terminated
KPSK040172
Dec 17, 2015Philips Medical Systems (Cleveland) Inc
BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emission Computed Tomography.
Terminated
KPSK080927
Dec 17, 2015Philips Medical Systems (Cleveland) Inc
BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging.
Terminated
KPSK062298
Dec 17, 2015Philips Medical Systems (Cleveland) Inc
BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.
Terminated
KPSK062298
Nov 4, 2015Siemens Medical Solutions USA, Inc.
e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, wh
Terminated
KPSK142006
Oct 7, 2015Toshiba American Medical Systems Inc
Celesteion PCA-9000A/2 PET/CT System
Terminated
KPSK140651
Sep 21, 2015GE Healthcare
PET Discovery ST 16
Terminated
KPSK041543
Sep 21, 2015GE Healthcare
PET Discovery LS
Terminated
KPSK040172
Aug 20, 2015Siemens Medical Solutions USA, Inc.
Siemens Intevo Series system, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomo
Terminated
KPSK142006
Aug 20, 2015Siemens Medical Solutions USA, Inc.
Siemens Symbia T Series, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomograph
Terminated
KPSK142006
Aug 20, 2015Siemens Medical Solutions USA, Inc.
Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine (NM) imaging system installed and used in only one location within an imaging fac
Terminated
KPSK142006
Aug 5, 2015Siemens Medical Solutions USA Inc.
Biograph 64-3R TruePoint w/ TrueV, Model Number 10097301
Terminated
KPSK123737
Aug 5, 2015Siemens Medical Solutions USA Inc.
Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302
Terminated
KPSK123737
Aug 5, 2015Siemens Medical Solutions USA Inc.
Biograph 6-4R TruePoint w/ TrueV, Model Number 10097290
Terminated
KPSK123737
Aug 5, 2015Siemens Medical Solutions USA Inc.
Biograph mCT Flow Edge-4R, Model Number 10528955
Terminated
KPSK123737
Aug 5, 2015Siemens Medical Solutions USA Inc.
SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743
Terminated
KPSK123737
Aug 5, 2015Siemens Medical Solutions USA Inc.
Biograph mCT X-4R, Model Number 10248670
Terminated
KPSK123737
Aug 5, 2015Siemens Medical Solutions USA Inc.
Biograph mCT S(64)-4R, Model Number 10248672
Terminated
KPSK123737
Aug 5, 2015Siemens Medical Solutions USA Inc.
Biograph mCT S(40)-4R, Model Number 10248671
Terminated
KPSK123737
Jul 22, 2015Philips Medical Systems (Cleveland) Inc
GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitabl
Terminated
KPSK081135
Jul 22, 2015Philips Medical Systems (Cleveland) Inc
GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable fo
Terminated
KPSK052640
Jul 22, 2015Philips Medical Systems (Cleveland) Inc
GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable f
Terminated
KPSK052640
Jul 22, 2015Philips Medical Systems (Cleveland) Inc
GEMINI TF 64 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitabl
Terminated
KPSK052640
Jul 22, 2015Philips Medical Systems (Cleveland) Inc
GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitabl
Terminated
KPSK052640
Jul 22, 2015Philips Medical Systems (Cleveland) Inc
GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a
Terminated
KPSK052640
Jul 22, 2015Philips Medical Systems (Cleveland) Inc
GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitab
Terminated
KPSK051170
Jun 11, 2015Philips Medical Systems (Cleveland) Inc
BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Terminated
KPSK080927
Jun 11, 2015Philips Medical Systems (Cleveland) Inc
BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Terminated
KPSK062298
Jun 11, 2015Philips Medical Systems (Cleveland) Inc
BrightView X (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Terminated
KPSK062298
Jun 11, 2015Philips Medical Systems (Cleveland) Inc
GEMINI TF Big Bore (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Terminated
KPSK081135
Jun 11, 2015Philips Medical Systems (Cleveland) Inc
GEMINI TF Ready (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Terminated
KPSK052640

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