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 4.3 for Win 64-bit
Nobel Biocare AB
4.3
In Commercial Distribution

  • 07332747215212 ()
300851

  • Radiology DICOM image processing application software
A software application to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data, Including functions for viewing, communication, printing, recording/ disc burning and/or image manipulation.
RADMEDIX, LLC
5
In Commercial Distribution

  • 00810035220379 ()


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

  • 00887868275852 ()
CG100

  • Radiology DICOM image processing application software
The aBSI is a software-only medical device that provides a fully quantitative assessment of a patient’s skeletal disease on a bone scan, as the fraction of the total skeleton weight. The user of this product is typically a health-care professional using the software to view the patient images and analysis results.
Exini Diagnostics AB
03
In Commercial Distribution

  • 07350002332030 ()
203

  • Radiology DICOM image processing application software
EXINI is intended to be used by trained health-care 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 imaging (NM) and computed tomography (CT). The software provides general Picture Archiving and Communications System (PACS) tools and a clinical application for oncology including lesion marking and analysis.
Exini Diagnostics AB
3
Not in Commercial Distribution

  • 07350002331033 ()
103

  • 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
aPROMISE is a softwareonly medical device that provides quantitative assessments of standardized uptake values (SUVs) for patients that are subject to examination by nuclear medicine (NM) imaging 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 intensityweighted 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

  • 07350002335017 ()
501

  • Radiology DICOM image processing application software
EXINI bone is a stand alone software intended for Windows OS platform. Users of the device can import whole body bone scintigraphy image data, view it using 2D medical image viewers, view and export quantitative analysis values.
Exini Diagnostics AB
03
In Commercial Distribution

  • 07350002333037 ()
303

  • Radiology DICOM image processing application software
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