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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No Description
I M T
3.2.1
In Commercial Distribution

  • 03760264690115 ()


  • Cardiovascular risk evaluation interpretive software
No Description
I M T
3.2.1 SR
In Commercial Distribution

  • 03760264690061 ()


  • Cardiovascular risk evaluation interpretive 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
4.0.5121.18001
In Commercial Distribution

  • B133ECTB40 ()


  • Cardiovascular risk evaluation interpretive software
7000 SPIROTRAC
VITALOGRAPH (IRELAND) LIMITED
7000
In Commercial Distribution

  • 05099169688001 ()
  • 65099169688003 ()


  • Cardiopulmonary parameter spot-check measurement software
MDN GlucoStabilizer® Insulin Dosing Calculator is designed for use by order of a physician for hospitalized patients. It is intended to evaluate the current as well as cumulative patient blood glucose values, and based on those measurements, calculate and recommend a dose of insulin or dextrose to drive the blood glucose level either up or down towards a predetermined target range. Once that target blood glucose range has been reached, the system’s function is to recommend dosing of insulin or dextrose for the purpose of maintaining the patient’s blood glucose level in that target range. The system is programmed to provide dosing calculations of insulin and dextrose for both adult and pediatric (ages 2-18) patients.
MEDICAL DECISION NETWORK, LLC
Insulin Dosing Calculator
In Commercial Distribution

  • 00861133000301 ()


  • Calculator, programmable
Hygieia d-Nav System Phone App - Android Operating System
HYGIEIA, INC.
V1m00b053d
In Commercial Distribution

  • 00860001044218 ()


  • Calculator, programmable
Hygieia d-Nav System Phone App - Apple iOS Operating System
HYGIEIA, INC.
V1m00b054i
In Commercial Distribution

  • 00860001044201 ()


  • Calculator, programmable
Genie Medical 2019.1 BAHS, USB ISO file for this software is 5712149025336
Oticon Medical AB
197603
In Commercial Distribution

  • 05712149025329 ()
M52650

  • Anchored bone-conduction hearing implant system
Genie Medical BAHS 2019.1 DVD ISO file for this software is 5712149025336
Oticon Medical AB
197965
In Commercial Distribution

  • 05712149025312 ()
197965

  • Anchored bone-conduction hearing implant system
Vascular Doppler system for arterial and venous testing capabilities with Smart-XT-Link software.
KOVEN TECHNOLOGY, INC.
Smartdop XT
In Commercial Distribution

  • 00894912002852 ()
Smartdop XT

  • Noninvasive vascular ultrasound system, line-powered
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