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 11, 2015 | Philips Medical Systems (Cleveland) Inc GEMINI TF PET/CT 64 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | K052640 |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc GEMINI TF PET/CT 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | K052640 |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc Ingenuity TF (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | K052640 |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | K051460 |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc TruFlight Select PET/CT 16-slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | K052640 |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc Gemini LXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | K052640 |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc Gemini GXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | K051170 |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc Precedence 6 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | K041218 |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | K041218 |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc Forte-JetStream AZ (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | K033254 |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc Gemini 16 PET/CT System (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | K041955 |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc AXIS (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | K964712 |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc FORTE (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | K982911 |
| May 28, 2015 | Philips Medical Systems (Cleveland) Inc Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical Systems.
The device is a diagnostic imaging system for fixed installations that combines Terminated |
KPS | K103483 |
| May 12, 2015 | Philips Medical Systems (Cleveland) Inc Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH Terminated |
KPS | K922080 K952684 |
| Mar 19, 2015 | Siemens Medical Solutions USA, Inc. E.CAM emission computed tomography system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographi Terminated |
KPS | K952109 |
| Mar 19, 2015 | Siemens Medical Solutions USA, Inc. Symbia E is a multi-purpose SPECT system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic Terminated |
KPS | K072567 |
| Mar 13, 2015 | GE Healthcare GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations.
Product Usage: The intended use of the system is to perform general Nuclear Medicine imaging proce Terminated |
KPS | K953801 |
| Feb 10, 2015 | Siemens Medical Solutions USA, Inc. The Siemens Symbia T series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. Terminated |
KPS | K082506 |
| Feb 10, 2015 | Siemens Medical Solutions USA, Inc. The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. Terminated |
KPS | K041166 |
| Jan 26, 2015 | Philips Medical Systems (Cleveland) Inc BrightView model number: 882478
BrightView X model number: 882480
BrightView XCT model number: 882482 and 882454
Medical Device for imaging Terminated |
KPS | K080927 |
| Jan 13, 2015 | Siemens Medical Solutions USA, Inc. Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans and imaging studies. Terminated |
KPS | K082506 |
| Jan 6, 2015 | Siemens Medical Solutions USA, Inc. e.cam -emission computed tomography system
Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomograp Terminated |
KPS | K952109 K982387 +1 |
| Jan 6, 2015 | Siemens Medical Solutions USA, Inc. The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation correction and anatomical localization.
The Symbia Intevo Series are xSPECT systems. These are SPECT Terminated |
KPS | K131634 |
| Jan 6, 2015 | Siemens Medical Solutions USA, Inc. The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and or Terminated |
KPS | K131634 |
| Jan 6, 2015 | Siemens Medical Solutions USA, Inc. The Siemens Symbia S series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and or Terminated |
KPS | K131634 |
| Dec 16, 2014 | Siemens Medical Solutions USA Inc. Biograph mCT S(40)-4R, System Material Number 10248671.
The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide regis Terminated |
KPS | K123737 |
| Dec 16, 2014 | Siemens Medical Solutions USA Inc. Biograph mCT S(64)-4R, System Material Number 10248672.
The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide regis Terminated |
KPS | K123737 |
| Dec 16, 2014 | Siemens Medical Solutions USA Inc. Biograph mCT X-4R, System Material Number 10248670.
The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registrat Terminated |
KPS | K123737 |
| Dec 16, 2014 | Siemens Medical Solutions USA Inc. Biograph mCT Flow 40-4R, System Material Number 10529159.
The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide reg Terminated |
KPS | K123737 |
| Dec 16, 2014 | Siemens Medical Solutions USA Inc. Biograph mCT Flow Edge-4R, System Material Number 10528955.
The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide r Terminated |
KPS | K123737 |
| Dec 16, 2014 | GE Healthcare, LLC Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H3100TN, H3100TT, H3100TR, H3100TW, H3100WZ, H2401MP, H2401MN, H2401MT, H2401MR, H2401MW, H2401NJ.
P Terminated |
KPS | K022960 K052434 +1 |
| Dec 16, 2014 | GE Healthcare, LLC Optima NM/CT 640, Models H3100YA, H3100YC.
Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in Terminated |
KPS | K022960 K052434 +1 |
| Dec 16, 2014 | GE Healthcare, LLC Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Models H3100RC, H3100RD, H2401LW.
Product Usage: The GE Discovery NM 630 system is a medical tool intended for use Terminated |
KPS | K022960 K052434 +1 |
| Dec 16, 2014 | GE Healthcare, LLC Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, H3100PP, H3100RA, H2401LS, H2401LZ, H2402LS.
Product Usage: The GE Discovery NM/CT 670 system is Terminated |
KPS | K022960 K052434 +1 |
| Dec 16, 2014 | GE Healthcare, LLC GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD, H2508PA, H2508PB, H2508PC, H2508PD.
Product Usage: The intended use of the Quasar system is to perform Terminated |
KPS | K022960 K052434 +1 |
| Dec 16, 2014 | GE Healthcare, LLC GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4, Infinia II VC, Infinia II VC Hawkeye, and Infinia II VC Hawkeye 4) Models: H3000WC, H3 Terminated |
KPS | K022960 K052434 +1 |
| Dec 12, 2014 | Philips Medical Systems, Inc. BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. Terminated |
KPS | K080927 |
| Dec 1, 2014 | Philips Medical Systems (Cleveland) Inc BrightView product code: 882478
BrightView X product code: 882480
BrightView XCT product code: 882482 and 882454 Terminated |
KPS | K062298 K080927 |
| Oct 22, 2014 | Siemens Medical Solutions USA, Inc. e.cam line of gamma camera systems
Used to detect or image the distribution of radionuclides in the body or organ. Terminated |
KPS | K952109 |
| Oct 22, 2014 | Siemens Medical Solutions USA, Inc. Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers.
It is used to detect or image the distribution of radionuclides in the body or organ. Terminated |
KPS | K082506 |
| Sep 29, 2014 | Siemens Medical Solutions USA, Inc. The Symbia Intevo series consists of the Intevo 16, Intevo 6 and Intevo 2. This manual also describes the Symbia Intevo Excel. The Symbia Intevo series integrates state-of-the-art SPECT and high quali Terminated |
KPS | K082506 K131634 |
| Sep 29, 2014 | Siemens Medical Solutions USA, Inc. The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The Terminated |
KPS | K082506 K131634 |
| Jul 11, 2014 | Siemens Medical Solutions USA, Inc. Symbia E camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body Terminated |
KPS | K131634 |
| Jul 11, 2014 | Siemens Medical Solutions USA, Inc. e.cam camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body ima Terminated |
KPS | K131634 |
| Jul 10, 2014 | Philips Medical Systems (Cleveland) Inc GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) a Terminated |
KPS | K052640 K081135 |
| Jul 2, 2014 | Philips Medical Systems (Cleveland) Inc BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat Panel Detector (FPD): product code 882454. Gamma camera for Single Photon Emission Computed Tomography (SPECT) Medical De Terminated |
KPS | K080927 |
| Jun 2, 2014 | Philips Medical Systems (Cleveland) Inc IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imagin Terminated |
KPS | K012009 K033326 +2 |
| Apr 26, 2014 | Philips Medical Systems (Cleveland) Inc Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143.
Used to produce images depicting the anatomical distribution o Terminated |
KPS | K922080 K952684 |
| Apr 16, 2014 | Philips Medical Systems (Cleveland) Inc Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc. Terminated |
KPS | K033326 |
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