Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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Device | LOGICON CARIES DETECTOR |
Generic Name | Analyzer, medical image |
Regulation Number | 892.2070 |
Applicant | CARESTREAM DENTAL LLC 1765 THE EXCHANGE ATLANTA, GA 30339 |
PMA Number | P980025 |
Date Received | 06/18/1998 |
Decision Date | 09/25/1998 |
Reclassified Date
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02/21/2020 |
Product Code |
MYN |
Docket Number | 98M-0856 |
Notice Date | 10/27/1998 |
Advisory Committee |
Radiology |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
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. |
Supplements: |
S001 S002 S003 S004 |
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