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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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DENTAL IMAGING SOFTWARE
CARESTREAM HEALTH, INC.
Dental Imaging Software
In Commercial Distribution

  • 60889975319575 ()
5319579

  • General-purpose dental x-ray system application software
CS IMAGING V7 WINDOWS EDITION
CARESTREAM HEALTH, INC.
CS Imaging Suite
In Commercial Distribution

  • 60889975314303 ()
5314307

  • General-purpose dental x-ray system application software
CS IMAGING V7 update only
CARESTREAM HEALTH, INC.
CS Imaging Software V7
Not in Commercial Distribution

  • 60889971745927 ()
1745926

  • General-purpose dental x-ray system application software
Dental Imaging software update only
CARESTREAM HEALTH, INC.
Dental Imaging Software
In Commercial Distribution

  • 60889971045072 ()
1045079

  • General-purpose dental x-ray system application software
LONG LENGTH IMAGING SW FOR DRX-ASCEND
CARESTREAM HEALTH, INC.
DRX - Ascend System
Not in Commercial Distribution

  • 60889971029881 ()
1029883

  • Basic diagnostic x-ray system application software
Site~Rite 8 Ultrasound System Console (Remanufactured)
Bard Access Systems, Inc.
9770600Y
In Commercial Distribution

  • 00801741138287 ()
9770600Y

  • Ultrasound imaging system operator console
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 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
LOGICON SITE LIC (UP TO 10) W/IWT
CARESTREAM DENTAL LLC
Logicon Caries Detector
Not in Commercial Distribution

  • 60192156851628 ()
8008690

  • General-purpose dental x-ray system application software
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