Logicon Caries Detector

GUDID 00868430000003

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.

G. A Industries

General-purpose dental x-ray system application software

• Primary Device ID: 00868430000003
• NIH Device Record Key: a09c35d6-2a9e-4052-b072-0c78a17c4237
• Commercial Distribution Discontinuation: 2017-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Logicon Caries Detector
• Version Model Number: 4.0
• 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: 1-800-944-6365
• Email: LogiconSupport@carestream.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868430000003 [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: 2014-09-24

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