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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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VIDA|vision is an interactive software-based viewing platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
VIDA DIAGNOSTICS, INC.
2.x
In Commercial Distribution

  • 00852426007008 ()


  • CT system application software
Digital Imaging software used with digital sensors to take x-ray images of teeth by dentists for diagnostic viewing of the images, archiving, and electronic transmission of images.
SUNI MEDICAL IMAGING, INC.
Advanced Imaging
In Commercial Distribution

  • 00851067007033 ()
400-1243S

  • General-purpose dental x-ray system application software
Digital Imaging software used with digital sensors to take x-ray images of teeth by dentists for diagnostic viewing of the images, archiving, and electronic transmission of images.
SUNI MEDICAL IMAGING, INC.
Advanced Imaging
In Commercial Distribution

  • 00851067007026 ()
400-1242S

  • General-purpose dental x-ray system application software
Dental Cloud Imaging Software
SOTA PRECISION OPTICS, INC.
1
In Commercial Distribution

  • 00851159007125 ()


  • General-purpose dental x-ray system application software
StrokeSENS LVO is a radiological computer-aided triage and notification (CADt) software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (L VO) in head CTA images. StrokeSENS LVO uses a software algorithm to identify suspected LVO findings. In the case of a suspected L VO, the system will send a notification to a pre-configured destination(s), notifying the clinicians of the existence of a suspected LVO that requires review. The notification system is intended to be used in parallel to the standard of care workflow to notify clinicians of the existence of the case earlier that they may have been notified as part of the standard of care workflow. Notifications may include a compressed preview of images. Notifications are meant for informational purposes only and are not intended for diagnostic use beyond notification. The StrokeSENS LVO device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of StrokeSENS LVO are intended to be used in conjunction with other patient information and based on professional judgement, to assist with triage/ prioritization of medical images. Notified clinicians are responsible for viewing full images per standard of care.
Circle Cardiovascular Imaging Inc
v2.x
In Commercial Distribution



  • CT system application software
No Description
Circle Cardiovascular Imaging Inc
3.x
In Commercial Distribution

  • 00882916000530 ()


  • CT system application software
No Description
Circle Cardiovascular Imaging Inc
2.1
In Commercial Distribution

  • 00882916000523 ()


  • CT system application software
No Description
Circle Cardiovascular Imaging Inc
1.x
In Commercial Distribution

  • 00882916000516 ()
v1.x and v2.0

  • CT system application software
A cloud-based, PACS-server software application that gives dental organizations web access to patient images that have been captured from any DICOM-enabled device.
APTERYX INC
2
In Commercial Distribution

  • 00685031000047 ()


  • General-purpose dental x-ray system application software
Dental imaging capture, enhance and display software for XVWeb.
APTERYX INC
1
In Commercial Distribution

  • 00685031000030 ()


  • General-purpose dental x-ray system application software
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