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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameanalyzer,medical image
Generic Nameanalyzer,medical image
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