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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 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
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
No Description
Guangdong Optomedic Technologies, Inc.
31103FA
In Commercial Distribution

  • 06973031299382 ()


  • Surgical microscope video camera, sterilizable
The uDR 596i Radiographic system is intended to be used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not for mammography.
UIH TECHNOLOGIES LLC
uDr 596i
In Commercial Distribution

  • 00810030350002 ()


  • Stationary basic diagnostic x-ray system, analogue
Selenia® Dimensions® C-View Software is a software feature where a standard digital mammography image is generated from data acquired during a standard resolution breast tomosynthesis scan.
Hologic, Inc.
C-View
In Commercial Distribution

  • 15420045500020 ()
SW-03052

  • Basic diagnostic x-ray system application software
No Description
EOS IMAGING
3.x
In Commercial Distribution

  • 03663999000412 ()


  • Basic diagnostic x-ray system application software
No Description
Mendaera, Inc.
C001-01
In Commercial Distribution

  • 00850062065000 ()

  • Weight: 75 Kilogram


  • Ultrasound imaging system operator console
RING/BLOCK ATTACH HARDWARE SET: (4) SHCS, (4)WASHER, (1)ALLEN WRENCH FOR CLOSED BACK RINGS
PMT CORPORATION
1201-37
In Commercial Distribution

  • 00650551098393 ()


  • Cervical spine immobilization system, single-use
IDI,RADIATION PROTECTION SYSTEM,LEADED ACRYLIC WINDOW,COMPASS CONTOUR SUSPENSION,SINGLE ARM,130MM THREADED HARDWARE#A610-0211-130
IMAGE DIAGNOSTICS, INC.
Compass Contour Suspended System with 1 Arm
In Commercial Distribution

  • 00850061871367 ()
A610-0211-130

  • Radiation shielding panel, portable/mobile
4 x 5 Lateral Pads with Adjustable Swing Away Mounting Hardware for BTX - Right (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368634 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLAS4X5PBR

  • Wheelchair head/trunk support, prefabricated
3 x 4 Lateral Pads with Adjustable Swing Away Mounting Hardware for BTX - Right (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368627 ()

  • Width: 4 Inch
  • Length: 3 Inch
PLLAS3X4PBR

  • Wheelchair head/trunk support, prefabricated
4 x 5 Lateral Pads with Adjustable Swing Away Mounting Hardware for BTX - Left (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368573 ()

  • Width: 5 Inch
  • Length: 4 Inch
PLLAS4X5PBL

  • Wheelchair head/trunk support, prefabricated
3 x 4 Lateral Pads with Adjustable Swing Away Mounting Hardware for BTX - Left (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368566 ()

  • Length: 3 Inch
  • Width: 4 Inch
PLLAS3X4PBL

  • Wheelchair head/trunk support, prefabricated
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