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.
| Device | LOGICON CARIES DETECTOR |
| Classification Name | Analyzer, Medical Image |
| Generic Name | Analyzer, Medical Image |
| Applicant | CARESTREAM DENTAL LLC |
| Date Received | 2013-02-19 |
| Decision Date | 2014-07-22 |
| PMA | P980025 |
| Supplement | S002 |
| Product Code | MYN |
| Advisory Committee | Radiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CARESTREAM DENTAL LLC 1765 The Exchange atlanta, GA 30339 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P980025 | | Original Filing |
| S004 |
2019-08-09 |
Normal 180 Day Track No User Fee |
| S003 |
2015-10-23 |
Normal 180 Day Track No User Fee |
| S002 |
2013-02-19 |
Normal 180 Day Track |
| S001 |
2006-05-25 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices