Videa Caries Assist

GUDID 00860009836808

Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize carious lesions. Videa Caries Assist is indicated for the review of bitewing (BW) radiographs acquired from adult patients aged 22 years or older.

Videahealth, Inc.

Dental x-ray image interpretive software

• Primary Device ID: 00860009836808
• NIH Device Record Key: df62ec61-76e4-49a5-b8db-6db337ad0d23
• Commercial Distribution Discontinuation: 2024-07-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Videa Caries Assist
• Version Model Number: VCA01B
• Company DUNS: 117170604
• Company Name: Videahealth, Inc.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009836808 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213795

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: 2
• Public Version Date: 2025-09-05
• Device Publish Date: 2023-01-23

On-Brand Devices [Videa Caries Assist]

• 00196852162192: Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes intraoral radio
• 00860009836808: Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes intraoral radio