LOGICON CARIES DETECTOR
FDA premarket approval P980025 · decided 1998-09-25
Approval details
- PMA number
- P980025
- Trade name
- LOGICON CARIES DETECTOR
- Generic name
- Analyzer, medical image
- Applicant
- Carestream Dental, LLC
- Date received
- 1998-06-18
- Decision date
- 1998-09-25
- Days to decision
- 99 days
- Decision code
- APRL
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Atlanta, GA
- 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.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE (K122427) | Carestream Dental, LLC | 2012-09-12 |