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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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.
SYNTERMED INCORPORATED
4.27720.29473
In Commercial Distribution

  • B133ECTB422102190 ()


  • Multidisciplinary medical image management software
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.
SYNTERMED INCORPORATED
4.2.7559.13747
In Commercial Distribution

  • B133ECTB422009110 ()


  • Multidisciplinary medical image management software
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.
SYNTERMED INCORPORATED
4.2.7003.28586
In Commercial Distribution

  • B133ECTB400 ()


  • Multidisciplinary medical image management software
SpectoMed provides real-time spatial-visualization of medical imaging allowing the manipulation, processing, review, analysis, communication and media interchange of multi-dimensional digital images of several modalities as defined by the DICOM standard, such as CT or MRI imaging datasets. Furthermore, SpectoMed aids the clinician in the preparation of a surgical intervention with measurements and import of compatible objects within the realistic spatial visuals of the patient’s anatomy as well as their intraoperative display. SpectoMed is intended as an aid for assessing patient images.
Specto Medical AG
V1
In Commercial Distribution

  • 07649998031011 ()


  • Multidisciplinary medical image management software
No Description
NEUROLOGICA CORP.
10-01148-001
In Commercial Distribution

  • 10815411020274 ()


  • General-purpose diagnostic x-ray phantom, test object
No Description
Shanghai May Skin Information Technology Co., Ltd.
MC10
In Commercial Distribution

  • 06975980570017 ()


  • Dermatoscopy system
No Description
Shanghai May Skin Information Technology Co., Ltd.
MC88
In Commercial Distribution

  • 06975980570000 ()


  • Dermatoscopy system
Adult Nasal/Oral Dual CO2 Sampling Cannula w/O2 Delivery, CO
TRINITY MEDICAL DEVICES INC.
TOT807
In Commercial Distribution

  • 00813880025939 ()
  • 00813880025823 ()


  • Nasal oxygen cannula, carbon-dioxide-sampling
Posterior Cervical, Rod, Prebent, CoCr, 3.5mm x 80mm, Co 28Cr 6Mo
Innovasis, Inc.
05-002-13-3580
In Commercial Distribution

  • M711050021335800 ()

  • Length: 80 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Bone-screw internal spinal fixation system rod
Posterior Cervical, Rod, Prebent, CoCr, 3.5mm x 60mm, Co 28Cr 6Mo
Innovasis, Inc.
05-002-13-3560
In Commercial Distribution

  • M711050021335600 ()

  • Length: 60 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Bone-screw internal spinal fixation system rod
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