|Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.|
|Trade Name||LOGICON CARIES DETECTOR|
|Classification Name||analyzer,medical image|
|Docket Number|| 98M-0856|
|Notice Date|| 10/27/1998|
|Expedited Review Granted?|| No|
|Approval Order Statement |
The logicon caries detector(tm) is a sotware decison aid for the diagnosis of caries that have penetrated into the dentin, on unrestored proximal surfaces of secondary dentition, through the analysis of digital intra-oral radiographic imagery. It is intended as an adjunct designed to work in conjunction with existing trextrophy rvg digital x-ray radiographic system with twi software version 3. 0 or higher.