Videa Dental Assist

GUDID 00860009836822

Videa Dental Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize suspect dental finding, historical treatment and normal anatomy features. Videa Dental Assist is indicated for the review of bitewing, periapical, and panoramic radiographs acquired from patients aged 3 years or older.

Videahealth, Inc.

Dental x-ray image interpretive software

• Primary Device ID: 00860009836822
• NIH Device Record Key: 2a281813-a611-43db-8788-73c708a4b826
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Videa Dental Assist
• Version Model Number: VDA01BPN
• 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
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• Phone: (617)299-1871
• Email: support@videa.ai
• 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	00860009836822 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232384

FDA Product Code

• MYN: Analyzer, Medical Image

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-23
• Device Publish Date: 2024-01-15

Devices Manufactured by Videahealth, Inc.

• 00860009836822 - Videa Dental Assist: 2024-01-23Videa Dental Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize suspect dental finding, historical treatment and normal anatomy features. Videa Dental Assist is indicated for the review of bitewing, periapical, and panoramic radiographs acquired from patients aged 3 years or older.
• 00860009836822 - Videa Dental Assist: 2024-01-23 Videa Dental Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize
• 00196852162192 - Videa Caries Assist: 2022-07-14 Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize