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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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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
No Description
EOS IMAGING
1.10
In Commercial Distribution

  • 03663999000153 ()


  • 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
EOS IMAGING
Workstation 1.6
In Commercial Distribution

  • 03663999000023 ()


  • Basic diagnostic x-ray system application software
Will3D is one of the components of a Picture Archiving and Communications System(PACS). Will3D is the software application that provides image viewing and manipulation in the diagnostic imaging setting.
HDX WILL CORP.
Will3D
In Commercial Distribution

  • 08800005200298 ()


  • General-purpose dental x-ray system application software
WillCeph is intended for use by orthodontists, oral surgeons, and their clinical staffs in storing and organizing images, including digitla photographs, x-rays, and others. The system includes the capability to trace a cephalometric x-ray, analyze the measurements taken, and make growth or surgical predictions
HDX WILL CORP.
WillCeph
In Commercial Distribution

  • 08800005200168 ()


  • General-purpose dental x-ray system application software
VisionX version 3.0.x
DÜRR DENTAL SE
E7300
In Commercial Distribution

  • E247E7300A10 ()


  • General-purpose dental x-ray system application software
No Description
DÜRR DENTAL SE
E7200
Not in Commercial Distribution

  • E247E72000 ()


  • General-purpose dental x-ray system application software
syngo.Interventional VB20; Medical Device syngo.Interventional VB20 is covered by NFJ to K143319 Syngo X-Workplace VD10
Siemens Healthcare GmbH
10849169
In Commercial Distribution

  • 04056869026305 ()


  • Basic diagnostic x-ray system application software
syngo.Interventional VB10;Medical Device syngo.Interventional VB10 is covered by NFJ to K143319 "Syngo X-Workplace SW VD10"
Siemens Healthcare GmbH
10849138
In Commercial Distribution

  • 04056869020518 ()


  • Basic diagnostic x-ray system application software
syngo.Interventional VA30;Medical Device syngo.Interventional VA30 is covered by NFJ to K042995 X-LEONARDO;
Siemens Healthcare GmbH
10849137
In Commercial Distribution

  • 04056869020501 ()


  • Basic diagnostic x-ray system application software
No Description
Siemens Healthcare GmbH
11665780
In Commercial Distribution

  • 04056869996172 ()


  • CT system application software
No Description
Siemens Healthcare GmbH
11546460
In Commercial Distribution

  • 04056869966922 ()


  • CT system application software
No Description
Siemens Healthcare GmbH
11665409
Not in Commercial Distribution

  • 04056869964331 ()


  • CT system application software
No Description
Siemens Healthcare GmbH
11583325
In Commercial Distribution

  • 04056869297293 ()


  • CT system application software
No Description
Siemens Healthcare GmbH
11583324
In Commercial Distribution

  • 04056869297286 ()


  • CT system application software
No Description
Siemens Healthcare GmbH
11583323
In Commercial Distribution

  • 04056869297279 ()


  • CT system application software
No Description
Siemens Healthcare GmbH
11546430
In Commercial Distribution

  • 04056869287416 ()


  • CT system application software
No Description
Siemens Healthcare GmbH
11546418
In Commercial Distribution

  • 04056869287393 ()


  • CT system application software
No Description
Siemens Healthcare GmbH
11546417
In Commercial Distribution

  • 04056869287386 ()


  • CT system application software
No Description
Siemens Healthcare GmbH
11546336
In Commercial Distribution

  • 04056869267463 ()


  • CT system application software
No Description
Siemens Healthcare GmbH
11546318
In Commercial Distribution

  • 04056869267425 ()


  • CT system application software
No Description
Siemens Healthcare GmbH
11546307
In Commercial Distribution

  • 04056869267340 ()


  • CT system application software
syngo.Interventional VB40; Medical Device syngo.Interventional VB40 is covered by NFJ to K190780 syngo Application Software VE20
Siemens Healthcare GmbH
11327988
In Commercial Distribution

  • 04056869248653 ()


  • Basic diagnostic x-ray system application software
syngo.Interventional VB30; Medical Device syngo.Interventional VB30 is covered by NFJ to K170747 syngo Application Software VD20
Siemens Healthcare GmbH
11327747
In Commercial Distribution

  • 04056869164311 ()


  • Basic diagnostic x-ray system application software
No Description
Siemens Healthcare GmbH
11664807
In Commercial Distribution

  • 04056869994536 ()


  • CT system application software
No Description
Siemens Healthcare GmbH
11546136
In Commercial Distribution

  • 04056869252230 ()


  • CT system application software
No Description
Siemens Healthcare GmbH
11270038
In Commercial Distribution

  • 04056869251233 ()


  • CT system application software
No Description
Siemens Healthcare GmbH
11270037
In Commercial Distribution

  • 04056869251226 ()


  • CT system application software
No Description
Siemens Healthcare GmbH
11270036
In Commercial Distribution

  • 04056869251219 ()


  • CT system application software
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