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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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No Description
icometrix NV
1
In Commercial Distribution

  • B621ICOMPANION103 ()


  • Self-care monitoring/reporting software
icobrain mr is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR images. icobrain mr consists of two distinct image processing pipelines: icobrain mr cross and icobrain mr long. icobrain mr cross is intended to provide volumes from images acquired at a single timepoint icobrain mr long is intended to provide changes in volumes between two images that were acquired on the same scanner, with the same image acquisition protocol and with same contrast at two different timepoints The results of icobrain mr cross cannot be compared with the results of icobrain mr long.
icometrix NV
5.14
In Commercial Distribution

  • B621ICOBRAINMR5X14Y0 ()


  • Radiology DICOM image processing application software
No Description
icometrix NV
1
In Commercial Distribution

  • B621ICOBRAINCTP10 ()


  • Radiology DICOM image processing application software
No Description
icometrix NV
6
In Commercial Distribution

  • B621ICOBRAIN60 ()


  • Radiology DICOM image processing application software
No Description
icometrix NV
5
In Commercial Distribution

  • B621ICOBRAIN50 ()


  • Radiology DICOM image processing application software
No Description
icometrix NV
4.0
In Commercial Distribution

  • B621ICOBRAIN40 ()


  • Radiology DICOM image processing application software
icobrain is software intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images.
icometrix NV
3
In Commercial Distribution

  • B621ICOBRAIN30 ()


  • Radiology DICOM image processing application software
icobrain is software intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images.
icometrix NV
2
In Commercial Distribution

  • B621ICOBRAIN20 ()


  • Radiology DICOM image processing application software
IQM is quality assurance device for medical linear accelerators for verifying the treatment beam.
iRT Systems GmbH
1013 (vers 1.3)
In Commercial Distribution

  • B50510130 ()


  • Accelerator system quality assurance device
The intended use of the device is to identify the patient and patient specific accessories and to guide the positioning of patients and accessories for radiosurgery or radiotherapy prodedures. The only location where the device is used is the radiologic diagnostic and radiation therapy department.
humediQ global GmbH
1.7
In Commercial Distribution

  • EHUQHQ0100707 ()
HQ01007

  • Radio-frequency identification patient positioning/tracking system application software
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