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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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MULTIFUNCTIONAL IMAGING, LLC
v1
In Commercial Distribution

  • 00860059002109 ()


  • PET system application software
Dental Cloud Imaging Software
Sota Cloud Corp.
1
In Commercial Distribution

  • 00860013687632 ()


  • General-purpose dental x-ray system application software
FREE SPIRIT
MEDACURE INC.
FS660
In Commercial Distribution

  • 00853223008014 ()


  • Freestanding patient lifting system, electrically-powered
Dental Cloud Imaging Software
SOTA PRECISION OPTICS, INC.
1
In Commercial Distribution

  • 00851159007125 ()


  • 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

  • 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
Logicon Caries Detector is a software tool for assisting in the diagnosis of proximal surface dental caries on radiographs acquired by a commercially available digital x-ray sensor system called RVG that is distributed in the United States by Carestream Dental, LLC. The software analyzes demineralization of the tooth material and compares it to a histological database of known caries problems to generate a probability of decay being present. A graphic interface displays an enlarged radiographic image outlining the potential lesion site on the tooth in question with separate plots of tooth density variations and lesion probability. Logicon Caries Detector v5.2 has a "Prescan" feature, a method for automatically scanning all of the interproximal surfaces in a bitewing radiograph of posterior teeth for interproximal caries. It displays caries outlines for all surfaces in one radiograph on one screen and allows dentist to view (1) screen result details (density change and decay probability for each outline), (2) save clinically important results and (3) explore others with the ROI tool. Doctor can build his own final diagnostic results screen combining his own manual results and adjusted PreScan results. PreScan uses same caries detection algorithms as original device; but now automatically opens the V-tool on each interproximal surface.
G. A Industries
5.2
Not in Commercial Distribution

  • 00868430000027 ()


  • General-purpose dental x-ray system application software
Logicon Caries Detector is a software tool for assisting in the diagnosis of proximal surface dental caries on radiographs acquired by a commercially available digital x-ray sensor system called RVG that is distributed in the United States by Carestream Dental, LLC. The software analyzes demineralization of the tooth material and compares it to a histological database of known caries problems to generate a probability of decay being present. A graphic interface displays an enlarged radiographic image outlining the potential lesion site on the tooth in question with separate plots of tooth density variations and lesion probability. PreScan is a New Feature in Logicon Caries Detector v5.1. It is a method for automatically scanning all the interproximal surfaces in a bitewing radiograph of posterior teeth for interproximal caries. It displays caries outlines for all surfaces in one radiograph on one screen and allows dentist to view (1) screen result details (density change and decay probability for each outline), (2) save clinically important results and (3) explore others with the ROI tool. Doctor can build his own final diagnostic results screen. PreScan uses same caries detection algorithms as original device; but now automatically opens the V-tool on each interproximal surface.
G. A Industries
5.1
Not in Commercial Distribution

  • 00868430000010 ()


  • General-purpose dental x-ray system application software
Logicon Caries Detector is a software tool for assisting in the diagnosis of proximal surface dental caries on radiographs acquired by a commercially available digital x-ray sensor system called RVG that is distributed in the United States by Carestream Dental, LLC. The software analyzes demineralization of the tooth material and compares it to a histological database of known caries problems to generate a probability of decay being present. A graphic interface displays an enlarged radiographic image outlining the potential lesion site on the tooth in question with separate plots of tooth density variations and lesion probability.
G. A Industries
4.0
Not in Commercial Distribution

  • 00868430000003 ()


  • General-purpose dental x-ray system application software
Dental imaging capture, enhance and display software.
APTERYX INC
3
In Commercial Distribution

  • 00685031000023 ()


  • General-purpose dental x-ray system application software
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