Logicon Caries Detector

GUDID 00868430000027

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.

G. A Industries

General-purpose dental x-ray system application software

• Primary Device ID: 00868430000027
• NIH Device Record Key: 51f7b067-d82a-423d-a258-df4caca9870e
• Commercial Distribution Discontinuation: 2018-01-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Logicon Caries Detector
• Version Model Number: 5.2
• Company DUNS: 926828869
• Company Name: G. A Industries
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-944-6365
• Email: LogiconSupport@carestream.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868430000027 [Primary]

FDA Product Code

• MYN: Analyzer,Medical Image

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-04-11
• Device Publish Date: 2016-05-11

On-Brand Devices [Logicon Caries Detector]

• 00868430000027: Logicon Caries Detector is a software tool for assisting in the diagnosis of proximal surface de
• 00868430000010: Logicon Caries Detector is a software tool for assisting in the diagnosis of proximal surface de
• 00868430000003: Logicon Caries Detector is a software tool for assisting in the diagnosis of proximal surface de