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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DTX Studio Clinic 4.2 for Mac
Nobel Biocare AB
4.2
Not in Commercial Distribution

  • 07332747202854 ()
300851

  • Radiology DICOM image processing application software
DTX Studio Clinic 4.5 for Mac
Nobel Biocare AB
4.5
In Commercial Distribution

  • 07332747221190 ()
300851

  • Radiology DICOM image processing application software
DTX Studio Clinic 4.5 for Win 64-bit
Nobel Biocare AB
4.5
In Commercial Distribution

  • 07332747221183 ()
300851

  • Radiology DICOM image processing application software
DTX Studio Clinic 4.4 for Mac
Nobel Biocare AB
4.4
In Commercial Distribution

  • 07332747219623 ()
300851

  • Radiology DICOM image processing application software
DTX Studio Clinic 4.4 for Win 64-bit
Nobel Biocare AB
4.4
In Commercial Distribution

  • 07332747219616 ()
300851

  • Radiology DICOM image processing application software
DTX Studio Clinic 4.3 for Mac
Nobel Biocare AB
4.3
In Commercial Distribution

  • 07332747215229 ()
300851

  • Radiology DICOM image processing application software
DTX Studio Clinic 4.3 for Win 64-bit
Nobel Biocare AB
4.3
In Commercial Distribution

  • 07332747215212 ()
300851

  • Radiology DICOM image processing application software
No Description
Biomet Orthopedics, LLC
CG100
Not in Commercial Distribution

  • 00887868275852 ()
CG100

  • Radiology DICOM image processing application software
PYLARIFY AI is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear medicine (NM) imaging, using PSMA PET/CT. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including marking of regions of interest and quantitative analysis.
Exini Diagnostics AB
02
In Commercial Distribution

  • 07350002337028 ()
702

  • Radiology DICOM image processing application software
PYLARIFY AI is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear medicine (NM) imaging, using PSMA PET/CT. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including marking of regions of interest and quantitative analysis.
Exini Diagnostics AB
02
In Commercial Distribution

  • 07350002336021 ()
602

  • Radiology DICOM image processing application software
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