Identifiers
- 510(k) Number
- K232384 FDA 510(k)
- FDA Product Code
- MYN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2070 FDA 510(k)
- Regulation Number
- 892.2070 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Videa Dental Assist is a Medical Image Analyzer, classified as a class 2 device. It is substantially equivalent and used in the field of Radiology.
The device is supplied by Videahealth, Inc. and has been cleared through the Traditional 510K pathway. It is intended for use in a medical setting, with a product code of MYN and regulation number 892.2070. The device has been assigned a K number, K232384, and has an FDA 510K authorization.
Frequently asked questions
What is the Videa Dental Assist used for?
The Videa Dental Assist is used in the field of Radiology as a Medical Image Analyzer.
How is the Videa Dental Assist supplied?
The device is supplied by Videahealth, Inc.
What is the regulatory classification of the Videa Dental Assist?
The Videa Dental Assist is classified as a class 2 device with a regulation number of 892.2070.
What is the product code of the Videa Dental Assist?
The product code of the Videa Dental Assist is MYN.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Dental AI Assistant for DSOs & Practices | Videa, Our company - Videa, VideaHealth Rebrands to Videa - Dental Industry News - Dentaltown
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232384 | Class II | Active |
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Manufacturer
- Manufacturer
- Videahealth, Inc.
Sources (1)
- FDA 510(k) K232384 24 fields · synced Sep 22, 2026