Logicon Caries Detector
Basic Information
- Brand Name
- Logicon Caries Detector
- Primary DI
- 00868430000027
- Version / Model
- 5.2
- Company Name
- G. A Industries
- Labeler DUNS
- 926828869
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-05-11
- Public Version
- 3
- Public Version Date
- 2018-04-11
- Public Version Status
- Update
- Public Device Record Key
- 51f7b067-d82a-423d-a258-df4caca9870e
- Distribution End Date
- 2018-01-14
Device Description
Logicon Caries Detector is a software tool for assisting in the diagnosis of proximal surface dental caries on radiographs acquired by a commercially available digital x-ray sensor system called RVG that is distributed in the United States by Carestream Dental, LLC. The software analyzes demineralization of the tooth material and compares it to a histological database of known caries problems to generate a probability of decay being present. A graphic interface displays an enlarged radiographic image outlining the potential lesion site on the tooth in question with separate plots of tooth density variations and lesion probability. Logicon Caries Detector v5.2 has a "Prescan" feature, a method for automatically scanning all of the interproximal surfaces in a bitewing radiograph of posterior teeth for interproximal caries. It displays caries outlines for all surfaces in one radiograph on one screen and allows dentist to view (1) screen result details (density change and decay probability for each outline), (2) save clinically important results and (3) explore others with the ROI tool. Doctor can build his own final diagnostic results screen combining his own manual results and adjusted PreScan results. PreScan uses same caries detection algorithms as original device; but now automatically opens the V-tool on each interproximal surface.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MYN | Analyzer,Medical Image | Radiology | 892.2070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40876 | General-purpose dental x-ray system application software | An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a general-purpose dental x-ray system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some application software routines or groups of routines (packages) must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00868430000027 | GS1 |
Customer Contacts
- Phone
- 800-944-6365
- [email protected]