Other products from "GE MEDICAL SYSTEMS, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00840682144209 5777746 JAK,KPS System, x-ray, tomography, computed,System, tomography, computed, emission 2 NA
2 00840682119658 5421698 IZL System, x-ray, mobile 2 NA
3 00195278003348 Navigate AMX Navigate Designated Medical Device Assembly IZL,MQB System, x-ray, mobile,Solid state x-ray imager (flat panel/digital imager) 2 AMX
4 00840682121071 4343 MQB Solid state x-ray imager (flat panel/digital imager) 2 Flashpad HD
5 00840682120982 600FP JAA System, x-ray, fluoroscopic, image-intensified 2 Precision
6 00840682120807 3543 MQB Solid state x-ray imager (flat panel/digital imager) 2 Flashpad HD
7 00840682120784 2530 MQB Solid state x-ray imager (flat panel/digital imager) 2 Flashpad HD
8 00840682119238 500D JAA System, x-ray, fluoroscopic, image-intensified 2 Precision
9 00840682143974 5607000-2 KPS System, tomography, computed, emission 2 O560 to 610 Upgrade
10 10840682142875 690 VCT Boost Upgrade KPS System, tomography, computed, emission 2 Discovery PET CT
11 00840682116732 5340000-7 MQB Solid state x-ray imager (flat panel/digital imager) 2 FlashPad
12 00840682116701 5340000-8 MQB Solid state x-ray imager (flat panel/digital imager) 2 FlashPad
13 00840682125574 Discovery CT A JAK System, x-ray, tomography, computed 2 Revolution
14 00840682146616 Apex 5590000-20 Revolution Apex - Designated System Medical Device JAK System, x-ray, tomography, computed 2 Revolution
15 00840682146357 OpenOC16 Console Upgrade KPS System, tomography, computed, emission 2 Discovery IQ
16 00840682143981 5607000 KPS System, tomography, computed, emission 2 O560 to D600 Upgrade
17 00840682143646 CT with Apex edition JAK System, x-ray, tomography, computed 2 Revolution
18 00840682142601 2 JAK System, x-ray, tomography, computed 2 SnapShot Freeze
19 00840682140713 CT with Quantix Upgrade JAK System, x-ray, tomography, computed 2 Revolution
20 00840682138796 160mm Detector Upgrade JAK System, x-ray, tomography, computed 2 Revolution
21 00840682123471 CT ES 5590000-15 Revolution CT ES - Designated Medical Device JAK System, x-ray, tomography, computed 2 Revolution
22 00840682118552 CT 5590000-6 Revolution CT - Designated System Medical Device JAK System, x-ray, tomography, computed 2 Revolution
23 00840682104364 5000 KPR,MQB System, x-ray, stationary,Solid state x-ray imager (flat panel/digital imager) 2 Definium
24 00840682102490 Discovery CT JAK System, x-ray, tomography, computed 2 Revolution
25 00195278454218 Legend OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY KPS,JAK System, tomography, computed, emission,System, x-ray, tomography, computed 2 Omni
26 00840682125703 IQ 2.0 KPS System, tomography, computed, emission 2 Discovery
27 00840682136709 XR656 HD Upgrade XR656HD UDI Label KPR,MQB System, X-Ray, Stationary,Solid State X-Ray Imager (Flat Panel/Digital Imager) 2 Discovery
28 00840682103107 IQ JAK,KPS System, x-ray, tomography, computed,System, tomography, computed, emission 2 Discovery
29 00840682146166 MI Digital Ready KPS,JAK System, tomography, computed, emission,System, x-ray, tomography, computed 2 Discovery
30 00840682143523 MI KPS,JAK System, tomography, computed, emission,System, x-ray, tomography, computed 2 Discovery
31 00840682120975 MI Digital Ready KPS,JAK System, tomography, computed, emission,System, x-ray, tomography, computed 2 Discovery
32 00840682108218 MI KPS,JAK System, tomography, computed, emission,System, x-ray, tomography, computed 2 Discovery
33 00840682103053 PETCT 610 KPS System, tomography, computed, emission 2 Discovery
34 00840682102995 PETCT 710 KPS System, tomography, computed, emission 2 Discovery
35 00195278098603 MI PET DMI Gen2 Image System Asm, No Detectors Installed, Common Weld Gantry, Manuf PET DMI Gen2 Image System Asm, No Detectors Installed, Common Weld Gantry, Manufacturing Make JAK,KPS System, x-ray, tomography, computed,System, tomography, computed, emission 2 Discovery
36 00840682146319 with Apex edition JAK System, x-ray, tomography, computed 2 Revolution CT
37 00840682141994 2.0 KPS System, tomography, computed, emission 2 Discovery MI Columbird mE2 Application SW
38 00840682123686 XR240amx HD Upgrade IZL,MQB System, x-ray, mobile,Solid state x-ray imager (flat panel/digital imager) 2 Optima
39 00840682142168 XR646 HD Upgrade KPR,MQB System, x-ray, stationary,Solid state x-ray imager (flat panel/digital imager) 2 Optima
40 00840682147316 TS-RT-100 TS-RT-100 Replacement Tape Blue for TruSignal AllFit sensor, 100 pcs DPZ Oximeter, ear 2 TruSignal SpO2
41 00840682147309 TS-RTW-100 TS-RTW-100 Replacement Tape Wide for TruSignal Wrap and Sensitive Skin sensor, 100 pcs DPZ Oximeter, ear 2 TruSignal SpO2
42 00840682147293 TS-RWM-24 TS-RWM-24 Replacement Foam Wrap Medium for TruSignal Sensitive Skin sensor, 24 pcs DPZ Oximeter, ear 2 TruSignal SpO2
43 00840682147286 TS-HB-3 TS-HB-3 Replacement Headband for TruSignal Ear sensor, 3 pcs DPZ Oximeter, ear 2 TruSignal SpO2
44 00840682147279 TS-RWS-24 TS-RWS-24 Replacement Foam Wrap Small for TruSignal Sensitive Skin sensor, 24 pcs DPZ Oximeter, ear 2 TruSignal SpO2
45 00840682147262 TS-RTB-100 TS-RTB-100 Replacement Tape Bear for TruSignal AllFit sensor, 100 pcs DPZ Oximeter, ear 2 TruSignal SpO2
46 00840682147255 TS-RWL-24 TS-RWL-24 Replacement Foam Wrap for TruSignal Wrap sensor, 24 pcs DPZ Oximeter, ear 2 TruSignal SpO2
47 00840682147248 TS-SND-3 TS-SND-3 Infant Foam Sandal Wrap for TruSignal Sensitive Skin sensor, 3 pcs DPZ Oximeter, ear 2 TruSignal SpO2
48 00840682147231 PACS 1.0 Designated Medical Device, Critical Care Suite PACS 1.0 QFM Radiological computer-assisted prioritization software for lesions 2 Critical Care Suite
49 00840682145749 XR240amx HD Upgrade Gen2 MQB,IZL Solid state x-ray imager (flat panel/digital imager),System, x-ray, mobile 2 Optima
50 00840682122351 XR240amx IZL,MQB System, x-ray, mobile,Solid state x-ray imager (flat panel/digital imager) 2 Optima
Other products with the same Product Codes "QFM, KPS"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00811852030196 Viz ANEURYSM Software Viz ANEURYSM v1.5 (2022-08-29) Viz ANEURYSM VIZ.AI, INC.
2 00810030350095 uMI 550 VM The uMI 550 PET/CT is a diagnostic imaging system that combines two existing ima The uMI 550 PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. This system is intended to be operated by qualified healthcare professionals. uMI VM UIH TECHNOLOGIES LLC
3 00810030350088 uMI 550 The uMI 550 PET/CT is a diagnostic imaging system that combines two existing ima The uMI 550 PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. This system is intended to be operated by qualified healthcare professionals. uMI UIH TECHNOLOGIES LLC
4 00195278592309 Legend OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY Omni G E MEDICAL SYSTEMS ISRAEL LTD.
5 00195278454218 Legend OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY Omni GE MEDICAL SYSTEMS, INC.
6 00195278421586 H3912AA 5875815-10 MyoSPECT GANTRY MyoSPECT G E MEDICAL SYSTEMS ISRAEL LTD.
7 00195278421579 H3912AB 5875815-20 MyoSPECT ES GANTRY MyoSPECT ES G E MEDICAL SYSTEMS ISRAEL LTD.
8 00195278217981 2.0 Critical Care Suite 2.0, Designated Medical Device Critical Care Suite GE MEDICAL SYSTEMS, INC.
9 00195278118295 H3911AB STARGATE NM GANTRY FINAL StarGuide G E MEDICAL SYSTEMS ISRAEL LTD.
10 00195278098603 MI PET DMI Gen2 Image System Asm, No Detectors Installed, Common Weld Gantry, Manuf PET DMI Gen2 Image System Asm, No Detectors Installed, Common Weld Gantry, Manufacturing Make Discovery GE MEDICAL SYSTEMS, INC.
11 B133NEUROQ382112070 3.80.20210429.143255 NeuroQ™ has been developed to aid in the assessment of human brain scans through NeuroQ™ has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in 240 different brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. The program can be used to compare activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. The program can also be used to for assisting in the assessment of prognosis in patients undergoing dementia evaluation with respect to the likelihood of progression of symptomatic disease, to provide analysis of amyloid uptake levels in the brain, and to evaluate and to provide a quantitative analysis of uptake levels in basal ganglia structures of the brain. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided. NeuroQ SYNTERMED INCORPORATED
12 B133NEUROQ382104290 3.80.20210429.143255 NeuroQ™ has been developed to aid in the assessment of human brain scans through NeuroQ™ has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in 240 different brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. The program can be used to compare activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. The program can also be used to for assisting in the assessment of prognosis in patients undergoing dementia evaluation with respect to the likelihood of progression of symptomatic disease, to provide analysis of amyloid uptake levels in the brain, and to evaluate and to provide a quantitative analysis of uptake levels in basal ganglia structures of the brain. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided. NeuroQ SYNTERMED INCORPORATED
13 B133NEUROQ300 3.8 NeuroQ™ has been developed to aid in the assessment of human brain scans through NeuroQ™ has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in 240 different brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. The program can be used to compare activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. The program can also be used to for assisting in the assessment of prognosis in patients undergoing dementia evaluation with respect to the likelihood of progression of symptomatic disease, to provide analysis of amyloid uptake levels in the brain, and to evaluate and to provide a quantitative analysis of uptake levels in basal ganglia structures of the brain. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided. NeuroQ SYNTERMED INCORPORATED
14 B133NEUROQ1 3.75.20171019 NeuroQ™ has been developed to aid in the assessment of human brain scans through NeuroQ™ has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in 240 different brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. The program can be used to compare activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. The program can also be used to for assisting in the assessment of prognosis in patients undergoing dementia evaluation with respect to the likelihood of progression of symptomatic disease, to provide analysis of amyloid uptake levels in the brain, and to evaluate and to provide a quantitative analysis of uptake levels in basal ganglia structures of the brain. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided. NeuroQ SYNTERMED INCORPORATED
15 B133NEUROQ0 3.6.20131127 NeuroQ™ has been developed to aid in the assessment of human brain scans through NeuroQ™ has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in 240 different brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. The program can be used to compare activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. The program can also be used to for assisting in the assessment of prognosis in patients undergoing dementia evaluation with respect to the likelihood of progression of symptomatic disease, to provide analysis of amyloid uptake levels in the brain, and to evaluate and to provide a quantitative analysis of uptake levels in basal ganglia structures of the brain. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided. NeuroQ SYNTERMED INCORPORATED
16 B133ECTB422112080 4.27720.29473 The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quan The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parameters of left-ventricular perfusion and function from gated SPECT & PET myocardial perfusion studies and for the evaluation of dynamic PET studies. These parameters are: perfusion, ejection fraction, end-diastolic volume, end-systolic volume, myocardial mass, transient ischemic dilatation (TID), analysis of coronary blood flow and coronary flow reserve, and assessment of cardiac mechanic dyssynchrony. In addition, the program offers the capability of providing the following diagnostic information: computer assisted visual scoring, prognostic information, and expert system image interpretation. The program can also be used for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface and for generation of the short axis, vertical, and horizontal long axis tomograms from the SPECT raw data using either filtered backprojection (FBP) or iterative reconstruction (MLEM/OSEM). The Emory Cardiac Toolbox can be used with any of the following Myocardial SPECT Protocols: Same Day and Two Day Sestamibi, Dual-Isotope (Tc-99m/Tl-201), Tetrofosmin, and Thallium, Rubidium-82, Rubidium-82 with CT-based attenuation correction, N-13-ammonia, FDG protocols, and user defined normal databases. This program was developed to run in the .NET operating system environment which can be executed on any PC, any nuclear medicine computer system, or through a web browser. In addition, the program can be used for the decision support in interpretation and automatic structured reporting of the study. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided. Emory Cardiac Toolbox SYNTERMED INCORPORATED
17 B133ECTB422102190 4.27720.29473 The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quan The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parameters of left-ventricular perfusion and function from gated SPECT & PET myocardial perfusion studies and for the evaluation of dynamic PET studies. These parameters are: perfusion, ejection fraction, end-diastolic volume, end-systolic volume, myocardial mass, transient ischemic dilatation (TID), analysis of coronary blood flow and coronary flow reserve, and assessment of cardiac mechanic dyssynchrony. In addition, the program offers the capability of providing the following diagnostic information: computer assisted visual scoring, prognostic information, and expert system image interpretation. The program can also be used for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface and for generation of the short axis, vertical, and horizontal long axis tomograms from the SPECT raw data using either filtered backprojection (FBP) or iterative reconstruction (MLEM/OSEM). The Emory Cardiac Toolbox can be used with any of the following Myocardial SPECT Protocols: Same Day and Two Day Sestamibi, Dual-Isotope (Tc-99m/Tl-201), Tetrofosmin, and Thallium, Rubidium-82, Rubidium-82 with CT-based attenuation correction, N-13-ammonia, FDG protocols, and user defined normal databases. This program was developed to run in the .NET operating system environment which can be executed on any PC, any nuclear medicine computer system, or through a web browser. In addition, the program can be used for the decision support in interpretation and automatic structured reporting of the study. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided. Emory Cardiac Toolbox SYNTERMED INCORPORATED
18 B133ECTB422009110 4.2.7559.13747 The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quan The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parameters of left-ventricular perfusion and function from gated SPECT & PET myocardial perfusion studies and for the evaluation of dynamic PET studies. These parameters are: perfusion, ejection fraction, end-diastolic volume, end-systolic volume, myocardial mass, transient ischemic dilatation (TID), analysis of coronary blood flow and coronary flow reserve, and assessment of cardiac mechanic dyssynchrony. In addition, the program offers the capability of providing the following diagnostic information: computer assisted visual scoring, prognostic information, and expert system image interpretation. The program can also be used for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface and for generation of the short axis, vertical, and horizontal long axis tomograms from the SPECT raw data using either filtered backprojection (FBP) or iterative reconstruction (MLEM/OSEM). The Emory Cardiac Toolbox can be used with any of the following Myocardial SPECT Protocols: Same Day and Two Day Sestamibi, Dual-Isotope (Tc-99m/Tl-201), Tetrofosmin, and Thallium, Rubidium-82, Rubidium-82 with CT-based attenuation correction, N-13-ammonia, FDG protocols, and user defined normal databases. This program was developed to run in the .NET operating system environment which can be executed on any PC, any nuclear medicine computer system, or through a web browser. In addition, the program can be used for the decision support in interpretation and automatic structured reporting of the study. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided. Emory Cardiac Toolbox SYNTERMED INCORPORATED
19 B133ECTB400 4.2.7003.28586 The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quan The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parameters of left-ventricular perfusion and function from gated SPECT & PET myocardial perfusion studies and for the evaluation of dynamic PET studies. These parameters are: perfusion, ejection fraction, end-diastolic volume, end-systolic volume, myocardial mass, transient ischemic dilatation (TID), analysis of coronary blood flow and coronary flow reserve, and assessment of cardiac mechanic dyssynchrony. In addition, the program offers the capability of providing the following diagnostic information: computer assisted visual scoring, prognostic information, and expert system image interpretation. The program can also be used for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface and for generation of the short axis, vertical, and horizontal long axis tomograms from the SPECT raw data using either filtered backprojection (FBP) or iterative reconstruction (MLEM/OSEM). The Emory Cardiac Toolbox can be used with any of the following Myocardial SPECT Protocols: Same Day and Two Day Sestamibi, Dual-Isotope (Tc-99m/Tl-201), Tetrofosmin, and Thallium, Rubidium-82, Rubidium-82 with CT-based attenuation correction, N-13-ammonia, FDG protocols, and user defined normal databases. This program was developed to run in the .NET operating system environment which can be executed on any PC, any nuclear medicine computer system, or through a web browser. In addition, the program can be used for the decision support in interpretation and automatic structured reporting of the study. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided. Emory Cardiac Toolbox SYNTERMED INCORPORATED
20 B133ECTB40 4.0.5121.18001 The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quan The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parameters of left-ventricular perfusion and function from gated SPECT & PET myocardial perfusion studies and for the evaluation of dynamic PET studies. These parameters are: perfusion, ejection fraction, end-diastolic volume, end-systolic volume, myocardial mass, transient ischemic dilatation (TID), analysis of coronary blood flow and coronary flow reserve, and assessment of cardiac mechanic dyssynchrony. In addition, the program offers the capability of providing the following diagnostic information: computer assisted visual scoring, prognostic information, and expert system image interpretation. The program can also be used for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface and for generation of the short axis, vertical, and horizontal long axis tomograms from the SPECT raw data using either filtered backprojection (FBP) or iterative reconstruction (MLEM/OSEM). The Emory Cardiac Toolbox can be used with any of the following Myocardial SPECT Protocols: Same Day and Two Day Sestamibi, Dual-Isotope (Tc-99m/Tl-201), Tetrofosmin, and Thallium, Rubidium-82, Rubidium-82 with CT-based attenuation correction, N-13-ammonia, FDG protocols, and user defined normal databases. This program was developed to run in the .NET operating system environment which can be executed on any PC, any nuclear medicine computer system, or through a web browser. In addition, the program can be used for the decision support in interpretation and automatic structured reporting of the study. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided. Emory Cardiac Toolbox SYNTERMED INCORPORATED
21 30815112020584 1.00 001771 Cardiac PET Processing Software HeartSee Cardiac PET Processing Software BRACCO DIAGNOSTICS INC
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23 M722XC22145P212210 1.1.1 ClearRead Xray Pneumothorax on Console Platform ClearRead Xray Pneumothorax RIVERAIN TECHNOLOGIES, INC.
24 M722X22145P212210 1.1.1 ClearRead Xray Pneumothorax on Xray Platform ClearRead Xray Pneumothorax RIVERAIN TECHNOLOGIES, INC.
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