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
NANO-X AI LTD
2.0
In Commercial Distribution

  • 07290018016169 ()


  • Radiology DICOM image processing application software
No Description
NANO-X AI LTD
1.0
In Commercial Distribution

  • 07290018016152 ()


  • Radiology DICOM image processing application software
No Description
NANO-X AI LTD
1.1
In Commercial Distribution

  • 07290018016145 ()


  • Radiology DICOM image processing application software
No Description
NANO-X AI LTD
1.1
In Commercial Distribution

  • 07290018016138 ()


  • Radiology DICOM image processing application software
No Description
NANO-X AI LTD
1.1
In Commercial Distribution

  • 07290018016114 ()


  • Radiology DICOM image processing application software
No Description
NANO-X AI LTD
1.0
Not in Commercial Distribution

  • 07290018016091 ()


  • Radiology DICOM image processing application software
No Description
NANO-X AI LTD
3.0.0
Not in Commercial Distribution

  • 07290018016008 ()


  • 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
PYLARIFY AI is a software only medical device that provides quantitative assessments of standardized uptake values (SUVs) for patients that are subject to examination by nuclear medicine (NM) imaging, using PSMA PET/CT, within the clinical application of oncology. The device performs by automatic organ and bone segmentation and lesions, selected by the user, will automatically be calculated into a lesion index (LI) and intensity-weighted total lesion volume (ITLV). The user of this product is typically a health-care professional using the software to review patient images and analyze results.
Exini Diagnostics AB
01
Not in Commercial Distribution

  • 07350002336014 ()
601

  • Radiology DICOM image processing application software
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