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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 Class Implantable

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Optellum Virtual Nodule Clinic - B816VNC2P30

Virtual Nodule Clinic (VNC) is a software application designed for trained medical professionals in the clinical management of patients with incidentally detected pulmonary nodules. The software assists the user with (1) management and tracking of patients with indeterminate pulmonary nodules (IPNs), available to all users and (2) a computer-aided diagnosis (CADx) function that takes a user-selected ROI and uses artificial intelligence to synthesize its morphological characteristics into a single value, the Optellum Lung Cancer Predictor (LCP) Score, only available to radiologists and pulmonologists.
OPTELLUM LTD
2.3
In Commercial Distribution

  • B816VNC2P30 ()
N/A

  • CT system application software

Optellum Virtual Nodule Clinic - B816VNC2P10

Virtual Nodule Clinic (VNC) is a software application designed for trained medical professionals in the clinical management of patients with incidentally detected pulmonary nodules. The software assists the user with (1) management and tracking of patients with indeterminate pulmonary nodules (IPNs), available to all users and (2) a computer-aided diagnosis (CADx) function that takes a user-selected ROI and uses artificial intelligence to synthesize its morphological characteristics into a single value, the Optellum Lung Cancer Predictor (LCP) Score, only available to radiologists and pulmonologists.
OPTELLUM LTD
2.1.0
In Commercial Distribution

  • B816VNC2P10 ()
N/A

  • CT system application software

VisionX - E247E7300A10

VisionX version 3.0.x
DÜRR DENTAL SE
E7300
In Commercial Distribution

  • E247E7300A10 ()


  • General-purpose dental x-ray system application software

VisionX - E247E7300

Dental Imaging Software. Software Version 2.x.x.
DÜRR DENTAL SE
E7300
In Commercial Distribution

  • E247E7300 ()


  • General-purpose dental x-ray system application software

DBSWIN - E247E7200A0

Dental Imaging Software. Software Version 5.x.x.
DÜRR DENTAL SE
E7200A
Not in Commercial Distribution

  • E247E7200A0 ()


  • General-purpose dental x-ray system application software

DBSWIN 5.11.0 - E247E72000

No Description
DÜRR DENTAL SE
E7200
Not in Commercial Distribution

  • E247E72000 ()


  • General-purpose dental x-ray system application software

StrokeSENS - B926SSSX10

StrokeSENS LVO is a radiological computer-aided triage and notification 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 (LVO) in head CTA images.
Circle Neurovascular Imaging Inc
v1.x
In Commercial Distribution

  • B926SSSX10 ()


  • CT system application software

Apex Cloud Software - D875403051

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.
MASTERLINK LLC
1
In Commercial Distribution

  • D875403051 ()


  • General-purpose dental x-ray system application software

Apex Capture Software - D875400101

Dental imaging capture, enhance and display software.
MASTERLINK LLC
1
In Commercial Distribution

  • D875400101 ()


  • General-purpose dental x-ray system application software

EVASOFT - D83399924908000

EVASOFT IMAGING SOFTWARE
ImageWorks
9992490800
In Commercial Distribution

  • D83399924908000 ()
9992490800

  • General-purpose dental x-ray system application software
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