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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceLOGICON CARIES DETECTOR
Classification Nameanalyzer,medical image
Generic Nameanalyzer,medical image
Applicant
CARESTREAM DENTAL LLC
1765 the exchange
atlanta, GA 30339
PMA NumberP980025
Date Received06/18/1998
Decision Date09/25/1998
Product Code
MYN[ Registered Establishments with 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 
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