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) |
|---|---|---|---|
| Jun 21, 2016 | Siemens 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 |
KPS | K141971 |
| Jun 21, 2016 | Siemens 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 |
KPS | K141971 |
| Jun 21, 2016 | Siemens 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 |
KPS | K141971 |
| Jun 15, 2016 | Siemens 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 |
KPS | K123737 |
| Jun 15, 2016 | Siemens 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 |
KPS | K123737 |
| Jun 15, 2016 | Siemens 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 |
KPS | K123737 |
| Jun 15, 2016 | Siemens 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 |
KPS | K123737 |
| May 25, 2016 | Philips Medical Systems (Cleveland) Inc BrightView XCT Upgrade Model 882454 Terminated |
KPS | K080927 |
| May 25, 2016 | Philips Medical Systems (Cleveland) Inc BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT) Terminated |
KPS | K080927 |
| May 25, 2016 | Philips Medical Systems (Cleveland) Inc BrightView X, model #882478; gamma camera designed for single or dual detector nuclear imaging Terminated |
KPS | K062298 |
| May 4, 2016 | Toshiba 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 |
KPS | K140651 |
| Mar 31, 2016 | Siemens 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 |
KPS | K142006 |
| Mar 4, 2016 | Philips 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 |
KPS | K090403 |
| Mar 4, 2016 | Philips 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 |
KPS | K090403 |
| Feb 26, 2016 | Siemens 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 |
KPS | K142006 |
| Feb 26, 2016 | Siemens 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 |
KPS | K142006 |
| Feb 10, 2016 | GE 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 |
KPS | K040172 |
| Feb 10, 2016 | GE 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 |
KPS | K081496 |
| Feb 10, 2016 | GE 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 |
KPS | K040172 |
| Feb 10, 2016 | GE 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 |
KPS | K040172 |
| Dec 17, 2015 | Philips Medical Systems (Cleveland) Inc BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emission Computed Tomography. Terminated |
KPS | K080927 |
| Dec 17, 2015 | Philips Medical Systems (Cleveland) Inc BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging. Terminated |
KPS | K062298 |
| Dec 17, 2015 | Philips Medical Systems (Cleveland) Inc BrightView are gamma cameras; Designed for single or dual detector nuclear imaging. Terminated |
KPS | K062298 |
| Nov 4, 2015 | Siemens 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 |
KPS | K142006 |
| Oct 7, 2015 | Toshiba American Medical Systems Inc Celesteion PCA-9000A/2 PET/CT System Terminated |
KPS | K140651 |
| Sep 21, 2015 | GE Healthcare PET Discovery ST 16 Terminated |
KPS | K041543 |
| Sep 21, 2015 | GE Healthcare PET Discovery LS Terminated |
KPS | K040172 |
| Aug 20, 2015 | Siemens 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 |
KPS | K142006 |
| Aug 20, 2015 | Siemens 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 |
KPS | K142006 |
| Aug 20, 2015 | Siemens 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 |
KPS | K142006 |
| Aug 5, 2015 | Siemens Medical Solutions USA Inc. Biograph 64-3R TruePoint w/ TrueV, Model Number 10097301 Terminated |
KPS | K123737 |
| Aug 5, 2015 | Siemens Medical Solutions USA Inc. Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302 Terminated |
KPS | K123737 |
| Aug 5, 2015 | Siemens Medical Solutions USA Inc. Biograph 6-4R TruePoint w/ TrueV, Model Number 10097290 Terminated |
KPS | K123737 |
| Aug 5, 2015 | Siemens Medical Solutions USA Inc. Biograph mCT Flow Edge-4R, Model Number 10528955 Terminated |
KPS | K123737 |
| Aug 5, 2015 | Siemens Medical Solutions USA Inc. SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743 Terminated |
KPS | K123737 |
| Aug 5, 2015 | Siemens Medical Solutions USA Inc. Biograph mCT X-4R, Model Number 10248670 Terminated |
KPS | K123737 |
| Aug 5, 2015 | Siemens Medical Solutions USA Inc. Biograph mCT S(64)-4R, Model Number 10248672 Terminated |
KPS | K123737 |
| Aug 5, 2015 | Siemens Medical Solutions USA Inc. Biograph mCT S(40)-4R, Model Number 10248671 Terminated |
KPS | K123737 |
| Jul 22, 2015 | Philips 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 |
KPS | K081135 |
| Jul 22, 2015 | Philips 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 |
KPS | K052640 |
| Jul 22, 2015 | Philips 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 |
KPS | K052640 |
| Jul 22, 2015 | Philips 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 |
KPS | K052640 |
| Jul 22, 2015 | Philips 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 |
KPS | K052640 |
| Jul 22, 2015 | Philips 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 |
KPS | K052640 |
| Jul 22, 2015 | Philips 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 |
KPS | K051170 |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | K080927 |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | K062298 |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc BrightView X (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | K062298 |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc GEMINI TF Big Bore (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | K081135 |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc GEMINI TF Ready (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | K052640 |
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