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 19, 2019 | GE Healthcare, LLC Discovery IQ
Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission
Tomography (PET) imaging and localization of emission activity in patient anatomy Open, Classified |
KPS | K141477 |
| Jun 19, 2019 | GE Healthcare, LLC Optima PET/CT 560, 560FX
Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission
Tomography (PET) imaging and localization of emission activity in pat Open, Classified |
KPS | K081496 |
| Jun 19, 2019 | GE Healthcare, LLC Discovery PET/CT 710
Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission
Tomography (PET) imaging and localization of emission activity in patient Open, Classified |
KPS | K133657 |
| Jun 19, 2019 | GE Healthcare, LLC Discovery PET/CT 610
Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission
Tomography (PET) imaging and localization of emission activity in patient Open, Classified |
KPS | K081496 |
| Jun 10, 2019 | Philips Medical Systems (Cleveland) Inc BrightView XCT , Model Number 882482 Terminated |
KPS | K080927 |
| Jun 10, 2019 | Philips Medical Systems (Cleveland) Inc BrightView X , Model Number 882478 Terminated |
KPS | K080927 |
| Jun 10, 2019 | Philips Medical Systems (Cleveland) Inc BrightView SPECT, Model Number 882480 Terminated |
KPS | K080927 |
| Jun 3, 2019 | Philips Medical Systems (Cleveland) Inc Vereos PET/CT, Model No. 882446
Product Usage:
Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruct Terminated |
KPS | K123599 |
| Dec 19, 2018 | Philips Medical Systems (Cleveland) Inc Ingenuity TF PET/CT (non-RoHS), Model Number 882456
This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subs Terminated |
KPS | K172406 |
| Nov 30, 2018 | Siemens Medical Solutions USA, Inc. Siemens Biograph Horizon PET/CT System,
Product Usage:
The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registrat Terminated |
KPS | K152880 K170904 |
| Nov 14, 2018 | GE Healthcare, LLC GE Healthcare Millennium MC Terminated |
KPS | K962738 |
| Nov 14, 2018 | GE Healthcare, LLC GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System Terminated |
KPS | K962738 |
| Nov 14, 2018 | GE Healthcare, LLC GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System Terminated |
KPS | K962738 |
| Oct 5, 2018 | Siemens Medical Solutions USA, Inc. EVO Excel, Emission Computed Tomographic System, Material Number 10910501 Terminated |
KPS | K162337 |
| Sep 28, 2018 | Siemens Medical Solutions USA, Inc. Biograph mCT:
a) S(64)-3R, Material Number 10248669
b) S (20) -3R, Material Number 10507786
c) Flow 20-4R, Material Number 10528958
d) m Flow 64-4R, Material Number 10529161
e) mCT S(40)-4R, Materia Terminated |
KPS | K173578 |
| Sep 28, 2018 | Siemens Medical Solutions USA, Inc. Biograph Horizon
a) 3R, Material Number 10532746
b) 4R, Material Number 10532748
The Siemens Biograph Horizon and Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emissio Terminated |
KPS | K170904 |
| Sep 4, 2018 | Philips Medical Systems (Cleveland) Inc Vereos PET/CT, Software version 2.0.1.
Model Number: 882446
Product Usage:
The Philips Vereos PET/CT system is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Terminated |
KPS | K123599 |
| May 24, 2018 | GE Healthcare, LLC Discovery NM/CT 670 Pro, model 5376204-70-54 Completed |
KPS | K093514 |
| May 24, 2018 | GE Healthcare, LLC Discovery NM/CT 670 ES, model 5376204-70-57 Completed |
KPS | K093514 |
| May 24, 2018 | GE Healthcare, LLC Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders s Completed |
KPS | K093514 |
| May 24, 2018 | GE Healthcare, LLC Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4 ring Terminated |
KPS | K161574 |
| May 24, 2018 | GE Healthcare, LLC Discovery MI Digital Ready Terminated |
KPS | K133657 |
| May 24, 2018 | GE Healthcare, LLC Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22 Terminated |
KPS | K141477 |
| May 21, 2018 | Philips Medical Systems (Cleveland) Inc Ingenuity Digital PET/CT System, Model 882446 with the following UDI's:
(01)00884838059559(21)900004
(01)00884838059559(21)900005
(01)00884838059559(21)900006
(01)00884838059559(21)900007
(01)0088483 Terminated |
KPS | K123599 |
| Mar 28, 2018 | Philips Medical Systems (Cleveland) Inc Ingenuity TF PET/CT 882442 Terminated |
KPS | K052640 |
| Feb 21, 2018 | Siemens Medical Solutions USA, Inc. Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information. Terminated |
KPS | K170904 |
| Feb 15, 2018 | Philips Medical Systems (Cleveland) Inc Ingenuity TF PET/CT, Model No. 882442
Product Usage:
The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system suitable for a wide range of d Terminated |
KPS | K052640 |
| Feb 3, 2018 | Philips Medical Systems (Cleveland) Inc Precedence 16 Model # 882350
Product Usage:
Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed t Terminated |
KPS | K041218 |
| Feb 3, 2018 | Philips Medical Systems (Cleveland) Inc Precedence 6 Model # 882351
Product Usage:
Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed to Terminated |
KPS | K041218 |
| Feb 3, 2018 | Philips Medical Systems (Cleveland) Inc BrightView Model 882480
Product Usage:
BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography Terminated |
KPS | K062298 |
| Feb 3, 2018 | Philips Medical Systems (Cleveland) Inc BrightView XCT Model 882482
Product Usage:
BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x Terminated |
KPS | K062298 |
| Feb 3, 2018 | Philips Medical Systems (Cleveland) Inc BrightView X, Model #882478
Product Usage:
BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomogra Terminated |
KPS | K062298 |
| Nov 7, 2017 | Siemens Medical Solutions USA, Inc. Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System
To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole b Terminated |
KPS | K162337 |
| Nov 7, 2017 | Siemens Medical Solutions USA, Inc. Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System
To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole Terminated |
KPS | K162337 |
| Nov 1, 2017 | Philips Medical Systems (Cleveland) Inc Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system Terminated |
KPS | K052640 |
| Oct 30, 2017 | GE Healthcare, LLC VariCam Completed |
KPS | K953801 |
| Oct 30, 2017 | GE Healthcare, LLC Discover VH/Millennium VG Nuclear Medicine Imaging System Completed |
KPS | K953801 |
| Sep 18, 2017 | Siemens Medical Solutions USA, Inc. Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Symbia Evo model 10910500, and Symbia Evo Excel model 10910501 de Terminated |
KPS | K162337 |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare Discovery NM/CT 570c X-ray system Terminated |
KPS | K083504 |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare Discovery NM/CT 670 CZT X-ray system Terminated |
KPS | K153402 |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system Terminated |
KPS | K093514 |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare Discovery Ml X-ray system Terminated |
KPS | K161574 |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare Discovery IQ X-ray system Terminated |
KPS | K141477 |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare Discovery Ml DR X-ray system Terminated |
KPS | K133657 |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare Discovery PET/CT 600,610, 690, 710: Optima PET/CT 560. 560FX X-ray system Terminated |
KPS | K081496 |
| Apr 6, 2017 | Philips Medical Systems (Cleveland) Inc BrightView X 3/8 model number 882478
BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT Terminated |
KPS | K062298 K080927 |
| Apr 6, 2017 | Philips Medical Systems (Cleveland) Inc BrightView X 3/4 model number 882479
BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT Terminated |
KPS | K062298 K080927 |
| Apr 6, 2017 | Philips Medical Systems (Cleveland) Inc BrightView XCT model number 882482
BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) Terminated |
KPS | K062298 K080927 |
| Apr 6, 2017 | Philips Medical Systems (Cleveland) Inc BrightView SPECT model number 882480
BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT Terminated |
KPS | K062298 K080927 |
| Mar 16, 2017 | Philips Medical Systems (Cleveland) Inc 882478: BrightView X designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circula Terminated |
KPS | K062298 K080927 |
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