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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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Quantib Prostate - 08719689791155

No Description
Quantib B.V.
1.3
Not in Commercial Distribution

  • 08719689791155 ()


  • Radiology DICOM image processing application software

Quantib Prostate - 08719689791131

No Description
Quantib B.V.
1.2
In Commercial Distribution

  • 08719689791131 ()


  • Radiology DICOM image processing application software

Quantib AI Node - 08719689791124

No Description
Quantib B.V.
2.3
In Commercial Distribution

  • 08719689791124 ()


  • Radiology DICOM image processing application software

Quantib Prostate - 08719689791117

No Description
Quantib B.V.
1.1
In Commercial Distribution

  • 08719689791117 ()


  • Radiology DICOM image processing application software

Quantib AI Node - 08719689791100

No Description
Quantib B.V.
2.2
In Commercial Distribution

  • 08719689791100 ()


  • Radiology DICOM image processing application software

ImmersiveTouch - B940IMMERSIVEVIEW50

ImmersiveTouch is a stand-alone modular software package that allows users to import, visualize, and segment medical images to create accurate 3D representations.
IMMERSIVETOUCH, INC.
V5.0
In Commercial Distribution

  • B940IMMERSIVEVIEW50 ()


  • Radiology DICOM image processing application software

ImmersiveTouch - B940IMMERSIVEVIEW0

The ImmersiveTouch simulators are intended as pre-operative software for simulating and evaluating surgical treatment options.
IMMERSIVETOUCH, INC.
V3.0
In Commercial Distribution

  • B940IMMERSIVEVIEW0 ()


  • Radiology DICOM image processing application software

Ikshana - B940IKSHANA0

Ikshana is a software device to display medical images. It includes functions for image review, image manipulation, measurements, and 3D visualization. Medical images may only be interpreted using an FDA-cleared display monitor that meets technical specifications that are reviewed and accepted by the FDA. Ikshana is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis. Display monitors used for reading medical images for diagnostic purposes must be FDA-approved radiology monitors. Ikshana software is indicated for use by qualified healthcare professionals, including, but not restricted to, radiologists, non-radiology specialists, physicians, and technologists. When accessing the Ikshana software from a wireless stereoscopic head-mounted display (HMD) or mobile device, the images viewed are for informational purposes only and are not intended for diagnostic use.
IMMERSIVETOUCH, INC.
V1.0
In Commercial Distribution

  • B940IKSHANA0 ()


  • Radiology DICOM image processing application software

3mensio Workstation - 08056304451224

No Description
Pie Medical Imaging B.V.
5.0
In Commercial Distribution

  • 08056304451224 ()


  • Radiology DICOM image processing application software

3mensio Workstation - 08056304451217

No Description
Pie Medical Imaging B.V.
8.0
In Commercial Distribution

  • 08056304451217 ()


  • Radiology DICOM image processing application software
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