LOGICON CARIES DETECTOR

Analyzer, Medical Image

FDA Premarket Approval P980025

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.

Pre-market Approval Supplement Details

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.

• Device: LOGICON CARIES DETECTOR
• Classification Name: Analyzer, Medical Image
• Generic Name: Analyzer, Medical Image
• Applicant: CARESTREAM DENTAL LLC
• Date Received: 1998-06-18
• Decision Date: 1998-09-25
• Notice Date: 1998-10-27
• PMA: P980025
• Supplement: S
• Product Code: MYN
• Docket Number: 98M-0856
• Advisory Committee: Radiology
• 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

Device ID	PMA	Supp
60192156851628	P980025	000
60192155942754	P980025	004