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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Diagnostic X-Ray System
OSKO, INC.
XR5
In Commercial Distribution

  • 00869126000420 ()


  • Stationary basic diagnostic x-ray system, analogue
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
Digital Imaging Software
DRGEM Corporation
RADMAX
In Commercial Distribution

  • 08800011170004 ()


  • Basic diagnostic x-ray system application software
The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device Identifier) is assigned based on the system model name, power specifications, and maximum x-ray tube voltage of the x-ray tube. *Power Specification (V) / maximum tube Voltage (kV) : 100-120 V~ / 125kV
DRGEM Corporation
GXR-EC40S
In Commercial Distribution

  • 08800011121907 ()


  • Stationary basic diagnostic x-ray system, analogue
The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device Identifier) is assigned based on the system model name, power specifications, and maximum x-ray tube voltage of the x-ray tube. *Power Specification (V) / maximum tube Voltage (kV) : 100-120 V~ / 125kV
DRGEM Corporation
GXR-EC32S
In Commercial Distribution

  • 08800011121891 ()


  • Stationary basic diagnostic x-ray system, analogue
The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device Identifier) is assigned based on the system model name, power specifications, and maximum x-ray tube voltage of the x-ray tube. *Power Specification (V) / maximum tube Voltage (kV) : 100-120 V~ / 125kV
DRGEM Corporation
GXR-EC20S
In Commercial Distribution

  • 08800011121877 ()


  • Stationary basic diagnostic x-ray system, analogue
The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device Identifier) is assigned based on the system model name, power specifications, and maximum x-ray tube voltage of the x-ray tube. *Power Specification (V) / maximum tube Voltage (kV) : 200-240 V~ / 125kV
DRGEM Corporation
GXR-EC32S
In Commercial Distribution

  • 08800011121785 ()


  • Stationary basic diagnostic x-ray system, analogue
The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device Identifier) is assigned based on the system model name, power specifications, and maximum x-ray tube voltage of the x-ray tube. *Power Specification (V) / maximum tube Voltage (kV) : 200-240 V~ / 125kV
DRGEM Corporation
GXR-EC20S
In Commercial Distribution

  • 08800011121761 ()


  • Stationary basic diagnostic x-ray system, analogue
100-240V~ / 150kV
DRGEM Corporation
FDR Clinica FGXR-U40S
In Commercial Distribution

  • 08800011121631 ()


  • Stationary basic diagnostic x-ray system, analogue
100-240V~ / 150kV
DRGEM Corporation
FDR Clinica FGXR-U32S
In Commercial Distribution

  • 08800011121617 ()


  • Stationary basic diagnostic x-ray system, analogue
220-230V~ / 150kV
DRGEM Corporation
FDR Clinica FGXR-C52S
In Commercial Distribution

  • 08800011121594 ()


  • Stationary basic diagnostic x-ray system, analogue
220-230V~ / 125kV
DRGEM Corporation
FDR Clinica FGXR-C52S
In Commercial Distribution

  • 08800011121587 ()


  • Stationary basic diagnostic x-ray system, analogue
110-120V~ / 125kV
DRGEM Corporation
FDR Clinica FGXR-C52S
In Commercial Distribution

  • 08800011121563 ()


  • Stationary basic diagnostic x-ray system, analogue
220-230V~ / 150kV
DRGEM Corporation
FDR Clinica FGXR-C40S
In Commercial Distribution

  • 08800011121556 ()


  • Stationary basic diagnostic x-ray system, analogue
220-230V~ / 125kV
DRGEM Corporation
FDR Clinica FGXR-C40S
In Commercial Distribution

  • 08800011121549 ()


  • Stationary basic diagnostic x-ray system, analogue
110-120V~ / 150kV
DRGEM Corporation
FDR Clinica FGXR-C40S
In Commercial Distribution

  • 08800011121532 ()


  • Stationary basic diagnostic x-ray system, analogue
110-120V~ / 125kV
DRGEM Corporation
FDR Clinica FGXR-C40S
In Commercial Distribution

  • 08800011121525 ()


  • Stationary basic diagnostic x-ray system, analogue
220-230V~ / 150kV
DRGEM Corporation
FDR Clinica FGXR-C32S
In Commercial Distribution

  • 08800011121518 ()


  • Stationary basic diagnostic x-ray system, analogue
220-230V~ / 125kV
DRGEM Corporation
FDR Clinica FGXR-C32S
In Commercial Distribution

  • 08800011121501 ()


  • Stationary basic diagnostic x-ray system, analogue
110-120V~ / 125kV
DRGEM Corporation
FDR Clinica FGXR-C32S
In Commercial Distribution

  • 08800011121488 ()


  • Stationary basic diagnostic x-ray system, analogue
No Description
EOS IMAGING
2.1
In Commercial Distribution

  • 03663999000337 ()


  • Basic diagnostic x-ray system application software
No Description
EOS IMAGING
1.0
Not in Commercial Distribution

  • 03663999000290 ()


  • Basic diagnostic x-ray system application software
No Description
EOS IMAGING
1.10
In Commercial Distribution

  • 03663999000153 ()


  • Basic diagnostic x-ray system application software
sterEOS workstation software
EOS IMAGING
Software 1.8
In Commercial Distribution

  • 03663999000054 ()


  • Basic diagnostic x-ray system application software
sterEOS workstation
EOS IMAGING
Workstation 1.8
In Commercial Distribution

  • 03663999000047 ()


  • Basic diagnostic x-ray system application software
sterEOS workstation software
EOS IMAGING
Software 1.6
In Commercial Distribution

  • 03663999000030 ()


  • Basic diagnostic x-ray system application software
sterEOS workstation
EOS IMAGING
Workstation 1.6
In Commercial Distribution

  • 03663999000023 ()


  • Basic diagnostic x-ray system application software
380V3~ / 150kV
DRGEM Corporation
FDR Clinica FGXR-82S
In Commercial Distribution

  • 08800011121471 ()


  • Stationary basic diagnostic x-ray system, analogue
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