LOGICON CARIES DETECTOR
FDA premarket approval P980025/S002 · decided 2014-07-22
Approval details
- PMA number
- P980025
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LOGICON CARIES DETECTOR
- Generic name
- Analyzer, medical image
- Applicant
- Carestream Dental, LLC
- Date received
- 2013-02-19
- Decision date
- 2014-07-22
- Days to decision
- 518 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Atlanta, GA
- Statement
- APPROVAL FOR THE ADDITION OF SOFTWARE MODULE PRESCAN TO LOGICON CARIES DETECTOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LOGICON CARIES DETECTOR AND HAS REVISED INDICATIONS FOR USE: THE LOGICON CARIES DETECTOR IS A SOFTWARE DEVICE THAT IS AN AID IN THE DIAGNOSIS OF CARIES THAT HAVE PENETRATED INTO THE DENTIN, ON UN-RESTORED PROXIMAL SURFACES OF SECONDARY DENTITION THROUGH THE STATISTICAL ANALYSIS OF DIGITAL INTRA-ORAL RADIOGRAPHIC IMAGERY. THE DEVICE PROVIDES ADDITIONAL IN
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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 |