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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 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
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
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
CS IMAGING CLIENT SERVER SUITE
CARESTREAM DENTAL LLC
CS Imaging Suite
Not in Commercial Distribution

  • 60192155943010 ()
5943014

  • General-purpose dental x-ray system application software
CSD LOGICON CARIES DETECTOR
CARESTREAM DENTAL LLC
Logicon Caries Detector
In Commercial Distribution

  • 60192155942754 ()
5942750

  • General-purpose dental x-ray system application software
Trophy Imaging 8
CARESTREAM DENTAL LLC
Trophy Imaging 8
In Commercial Distribution

  • 60192155500688 ()
5500681

  • General-purpose dental x-ray system application software
CS IMAGING 8 SUITE
CARESTREAM DENTAL LLC
CS Imaging Suite
In Commercial Distribution

  • 60192155500671 ()
5500673

  • General-purpose dental x-ray system application software
TROPHY 3D IMAGING
CARESTREAM DENTAL LLC
Trophy 3D Imaging
In Commercial Distribution

  • 60192155319556 ()
5319553

  • General-purpose dental x-ray system application software
CS Imaging Suite
CARESTREAM DENTAL LLC
CS Imaging Suite
In Commercial Distribution

  • 60192155314308 ()
5314307

  • General-purpose dental x-ray system application software
TBS iNsight is a software application provided for use as a complement to bone mineral density (BMD) acquired from dual energy X-ray absorptiometry (DXA) and other clinical risk factors for osteoporosis and fragility fracture. It calculates a score (Trabecular Bone Score - TBS) derived from the texture of the DXA image of the anterior-posterior (AP) lumbar spine and has been shown to be related to bone microarchitecture. The method analyzes X-ray based images acquired by DXA imaging systems and produces the TBS based on the computation of an Adapted Experimental Variogram (modified fractal-like approach). This variogram is used to measure the degree of spatial variation between pairs of data points in a spatial dimension of a region of a digital image.
medimaps group SA
4.0
In Commercial Distribution

  • B214OSTBSIV400 ()


  • Basic diagnostic x-ray system application software
NobelClinician 3.1 for MAC
Nobel Biocare AB
3.1
Not in Commercial Distribution

  • 07332747125177 ()
101560

  • General-purpose dental x-ray system application software
NobelClinician 3.1 for Windows 64-bit
Nobel Biocare AB
3.1
Not in Commercial Distribution

  • 07332747125160 ()
101560

  • General-purpose dental x-ray system application software
NobelClinician 3.1 for Windows 32-bit
Nobel Biocare AB
3.1
Not in Commercial Distribution

  • 07332747125153 ()
101560

  • General-purpose dental x-ray system application software
NobelClinician 2.8 for Windows MAC
Nobel Biocare AB
2.8
Not in Commercial Distribution

  • 07332747124972 ()
101560

  • General-purpose dental x-ray system application software
NobelClinician 2.8 for Windows 64-bit
Nobel Biocare AB
2.8
Not in Commercial Distribution

  • 07332747124958 ()
101560

  • General-purpose dental x-ray system application software
NobelClinician 2.8 for Windows 32-bit
Nobel Biocare AB
2.8
Not in Commercial Distribution

  • 07332747124941 ()
101560

  • General-purpose dental x-ray 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
SW APP A820 TDD PATIENT PROG V2.X
MEDTRONIC, INC.
A820
In Commercial Distribution

  • 00763000632793 ()


  • Infusion pump programmer
SW APP A810 TDD CLINICIAN PROG V2.X
MEDTRONIC, INC.
A810
In Commercial Distribution

  • 00763000632786 ()


  • Infusion pump programmer
PRGM 8835 PERSONAL THRPY MG2 SRVC US
MEDTRONIC, INC.
8835-SVC
In Commercial Distribution

  • 00763000875701 ()


  • Infusion pump programmer
PRGM 8835 PERSONAL THRPY MG2 RFRB US
MEDTRONIC, INC.
8835-RFB
In Commercial Distribution

  • 00763000875695 ()


  • Infusion pump programmer
Roentgen Works 6.5.0 is a PACS, RIS, and Viewer.
Brit Systems, LLC
6.5.0
In Commercial Distribution

  • 00850631008728 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software
Roentgen Works 6.4.1 is a PACS, RIS, and Viewer.
Brit Systems, LLC
6.4.1
In Commercial Distribution

  • 00850631008711 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software
Roentgen Works 6.4.0 is a PACS, RIS, and Viewer.
Brit Systems, LLC
6.4.0
In Commercial Distribution

  • 00850631008704 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software
Roentgen Works 6.3.2 is a PACS, RIS, and Viewer.
Brit Systems, LLC
6.3.2
In Commercial Distribution

  • 00850631008698 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software
Roentgen Works 6.3.1 is a PACS, RIS, and Viewer.
Brit Systems, LLC
6.3.1
In Commercial Distribution

  • 00850631008681 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software
Roentgen Works 6.3.0 is a PACS, RIS, and Viewer.
Brit Systems, LLC
6.3.0
In Commercial Distribution

  • 00850631008674 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software
Roentgen Works 6.2.1 is a PACS, RIS, and Viewer.
Brit Systems, LLC
6.2.1
In Commercial Distribution

  • 00850631008667 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software
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