Analyzer, Medical Image
Basic Information
- Device Name
- Analyzer, Medical Image
- Trade Name
- LOGICON CARIES DETECTOR
- PMA Number
- P980025
- Supplement Number
- S002
- Device Class
- FDA Class 2
- Product Code
- MYN
- Generic Name
- Analyzer, medical image
- Regulation Number
- 892.2070
- Medical Specialty
- Radiology
- Advisory Committee
- Radiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- July 22, 2014
- Date Received
- February 19, 2013
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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 INFORMATION FOR THE CLINICIAN TO USE IN HIS/HER DIAGNOSIS OF A TOOTH SURFACE SUSPECTED OF BEING CARIOUS. IT IS DESIGNED TO WORK IN CONJUNCTION WITH AN EXISTING CARESTREAM DENTAL RVG DIGITAL X-RAY RADIOGRAPHIC SYSTEM WITH DENTAL IMAGING SOFTWARE (DIS) FOR WINDOWS XP OR HIGHER.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MYN | Analyzer, Medical Image | FDA class 2 | Radiology |