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)
Jun 19, 2019GE 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
KPSK141477
Jun 19, 2019GE 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
KPSK081496
Jun 19, 2019GE 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
KPSK133657
Jun 19, 2019GE 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
KPSK081496
Jun 10, 2019Philips Medical Systems (Cleveland) Inc
BrightView XCT , Model Number 882482
Terminated
KPSK080927
Jun 10, 2019Philips Medical Systems (Cleveland) Inc
BrightView X , Model Number 882478
Terminated
KPSK080927
Jun 10, 2019Philips Medical Systems (Cleveland) Inc
BrightView SPECT, Model Number 882480
Terminated
KPSK080927
Jun 3, 2019Philips 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
KPSK123599
Dec 19, 2018Philips 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
KPSK172406
Nov 30, 2018Siemens 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
KPSK152880
K170904
Nov 14, 2018GE Healthcare, LLC
GE Healthcare Millennium MC
Terminated
KPSK962738
Nov 14, 2018GE Healthcare, LLC
GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System
Terminated
KPSK962738
Nov 14, 2018GE Healthcare, LLC
GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System
Terminated
KPSK962738
Oct 5, 2018Siemens Medical Solutions USA, Inc.
EVO Excel, Emission Computed Tomographic System, Material Number 10910501
Terminated
KPSK162337
Sep 28, 2018Siemens 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
KPSK173578
Sep 28, 2018Siemens 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
KPSK170904
Sep 4, 2018Philips 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
KPSK123599
May 24, 2018GE Healthcare, LLC
Discovery NM/CT 670 Pro, model 5376204-70-54
Completed
KPSK093514
May 24, 2018GE Healthcare, LLC
Discovery NM/CT 670 ES, model 5376204-70-57
Completed
KPSK093514
May 24, 2018GE 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
KPSK093514
May 24, 2018GE Healthcare, LLC
Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4 ring
Terminated
KPSK161574
May 24, 2018GE Healthcare, LLC
Discovery MI Digital Ready
Terminated
KPSK133657
May 24, 2018GE Healthcare, LLC
Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22
Terminated
KPSK141477
May 21, 2018Philips 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
KPSK123599
Mar 28, 2018Philips Medical Systems (Cleveland) Inc
Ingenuity TF PET/CT 882442
Terminated
KPSK052640
Feb 21, 2018Siemens 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
KPSK170904
Feb 15, 2018Philips 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
KPSK052640
Feb 3, 2018Philips 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
KPSK041218
Feb 3, 2018Philips 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
KPSK041218
Feb 3, 2018Philips 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
KPSK062298
Feb 3, 2018Philips 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
KPSK062298
Feb 3, 2018Philips 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
KPSK062298
Nov 7, 2017Siemens 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
KPSK162337
Nov 7, 2017Siemens 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
KPSK162337
Nov 1, 2017Philips Medical Systems (Cleveland) Inc
Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
Terminated
KPSK052640
Oct 30, 2017GE Healthcare, LLC
VariCam
Completed
KPSK953801
Oct 30, 2017GE Healthcare, LLC
Discover VH/Millennium VG Nuclear Medicine Imaging System
Completed
KPSK953801
Sep 18, 2017Siemens 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
KPSK162337
May 19, 2017GE Healthcare, LLC
GE Healthcare Discovery NM/CT 570c X-ray system
Terminated
KPSK083504
May 19, 2017GE Healthcare, LLC
GE Healthcare Discovery NM/CT 670 CZT X-ray system
Terminated
KPSK153402
May 19, 2017GE Healthcare, LLC
GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system
Terminated
KPSK093514
May 19, 2017GE Healthcare, LLC
GE Healthcare Discovery Ml X-ray system
Terminated
KPSK161574
May 19, 2017GE Healthcare, LLC
GE Healthcare Discovery IQ X-ray system
Terminated
KPSK141477
May 19, 2017GE Healthcare, LLC
GE Healthcare Discovery Ml DR X-ray system
Terminated
KPSK133657
May 19, 2017GE Healthcare, LLC
GE Healthcare Discovery PET/CT 600,610, 690, 710: Optima PET/CT 560. 560FX X-ray system
Terminated
KPSK081496
Apr 6, 2017Philips 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
KPSK062298
K080927
Apr 6, 2017Philips 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
KPSK062298
K080927
Apr 6, 2017Philips 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
KPSK062298
K080927
Apr 6, 2017Philips 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
KPSK062298
K080927
Mar 16, 2017Philips 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
KPSK062298
K080927

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