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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 LungVision System is designed to enable users to segment previously acquired 3D CT data sets and overlay and register these 3D segmented data sets with live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures. The mobile system cart is an optional unit to place the LUNGVISIONTM Main Unit and router, also used for storing all the system components: LV Board, Tablet, DVD reader, Keyboard, Mouse and cables.
BODY VISION MEDICAL LTD
Core
In Commercial Distribution

  • 07290017652085 ()
LV1055002

  • Virtual bronchoscopic navigation PACS software
The LungVision System is designed to enable users to segment previously acquired 3D CT data sets and overlay and register these 3D segmented data sets with live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures.
BODY VISION MEDICAL LTD
Core
In Commercial Distribution

  • 07290017652030 ()
LV1055001

  • Virtual bronchoscopic navigation PACS software
The SafeCT is a software package of a PACS server, which is connected to the clinics' Local Area Network (LAN), receives, processes and transfers CT images, using the DICOM protocol. The processing enhances image quality by reduction of the image noise.
MEDIC VISION - IMAGING SOLUTIONS LTD
1.2
In Commercial Distribution

  • 07290016836004 ()


  • CT system application software
CT LVAS (CT:V) software is a non-invasive image processing technology that utilizes a paired inspiration-expiration CT to quantify and visualize regional and global ventilation within the lungs. The device provides physicians with additional clinical data to support management of pulmonary disease. Quantification and visualizations are provided in the form of a report.
4DMEDICAL LIMITED
1.x
In Commercial Distribution

  • 19356870000021 ()


  • CT system application software
The XV Lung Ventilation Analysis Software is a software-based image processing technology that analyzes cinefluorograph images in combination with a CT image to quantify ventilation of pulmonary tissue, thereby providing support to physicians in their assessment of patients with lung diseases. The XV Lung Ventilation Analysis Software measures the tissue motion of the lung, at all locations throughout the lung, and at all phases of the breath. It uses these motion measurements to calculate the 4-dimensional (4D) ventilation of lung tissues. Quantification and statistics are provided in the form of a Report. The key outputs are: • The tidal volume (i.e. total lung ventilation), presented as a single value; • Visualization of lung ventilation with color-defined specific ventilation ranges; • The heterogeneity of lung ventilation, presented as three values; and • Ventilation graph/ histogram of the classified lung voxel’s relative frequencies including ventilation defect percentage.
4DMEDICAL LIMITED
XV LVAS
In Commercial Distribution

  • 19356870000014 ()


  • CT system application software
The ReJoyce is a rehabilitation device intended to increase the strength of muscles and the range of motion of joints of the upper extremities. The ReJoyce helps patients to retrain and condition their muscles by using their hands and arms to play interactive computer games. The activities required by the computer games are similar to tasks used in everyday life, such as pouring a drink or opening a jar. Practicing these motions will help patients to replicate them in real life.
Rehabtronics Inc
RV10
In Commercial Distribution

  • 17540176010002 ()


  • Virtual-display arm rehabilitation system, non-gravity-compensating
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Nethasp Holter for additional work station, Kit The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NH301-N
In Commercial Distribution

  • 07290110252755 ()
HASP-SW-K-NH301-Net-1

  • Electrocardiographic long-term ambulatory recording analyser
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Network Solution for NH300 - No additional users The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NH300-N
In Commercial Distribution

  • 07290110252731 ()
HASP-SW-KNH300-3N-M-02

  • Electrocardiographic long-term ambulatory recording analyser
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Upgrade from SOFT-NH300-2/3 to SOFT-NH301-4,K The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NH300 Ana to 301
In Commercial Distribution

  • 07290110252717 ()
SW NH300 Ana to 301

  • Electrocardiographic long-term ambulatory recording analyser
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - ECG Management System NEMS-Q, SQL Base License The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NEMS-Q1
In Commercial Distribution

  • 07290110252557 ()
HASP-SW-K-NEMS-Q-01

  • Patient-administration information system application software
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