|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||LOGICON CARIES DETECTOR|
|Classification Name||analyzer,medical image|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of software module prescan to logicon caries detector. The device, as modified, will be marketed under the trade name logicon caries detector and has revised indications for use: the logicon caries detector is a software device that is an aid in the diagnosis of caries that have penetrated into the dentin, on un-restored proximal surfaces of secondary dentition through the statistical analysis of digital intra-oral radiographic imagery. The device provides additional information for the clinician to use in his/her diagnosis of a tooth surface suspected of being carious. It is designed to work in conjunction with an existing carestream dental rvg digital x-ray radiographic system with dental imaging software (dis) for windows xp or higher.