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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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PROG 8835 PERSONAL THERAPY MGR ROHS
MEDTRONIC, INC.
8835
In Commercial Distribution

  • 00643169518957 ()


  • Infusion pump programmer
No Description
Icad, Inc.
DSC012-03
In Commercial Distribution

  • 00850008977190 ()


  • Basic diagnostic x-ray system application software
No Description
Icad, Inc.
DSC012-02
In Commercial Distribution

  • 00850008977183 ()


  • Basic diagnostic x-ray system application software
No Description
Icad, Inc.
3.0
In Commercial Distribution

  • 00850008977176 ()


  • Basic diagnostic x-ray system application software
PROG 8835 PERSONAL THERAPY MGR GRC
MEDTRONIC, INC.
8835
In Commercial Distribution

  • 00643169974791 ()


  • Infusion pump programmer
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
IMAGEXL XRAY SOFTWARE VERSION 4 BASE
PROFESSIONAL ECONOMICS BUREAU OF AMERICA INC
4
In Commercial Distribution

  • 00861787000306 ()


  • General-purpose dental x-ray system application software
No Description
Icad, Inc.
2.1
In Commercial Distribution

  • 00858012005960 ()


  • Basic diagnostic x-ray system application software
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