Identifiers
- 510(k) Number
- K251002 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)
Videa Dental AI is a medical image analyzer designed for use in the field of radiology. It functions as a software platform that assists dental clinicians in the identification and documentation of clinical findings.
This device is authorized under FDA 510K clearance, identified by k-number K251002. It is classified as a class 2 medical device under regulation number 892.2070.
Frequently asked questions
What is the primary function of Videa Dental AI?
Videa Dental AI is a medical image analyzer software platform. It is designed to assist dental clinicians by supporting the identification and documentation of clinical findings within radiology images.
What is the regulatory status of this device?
Videa Dental AI is authorized under FDA 510K clearance, identified by k-number K251002. It is classified as a class 2 medical device under regulation number 892.2070.
Which medical specialty is this device intended for?
This device is intended for use in the field of radiology. It is categorized under the radiology advisory committee and is designed to support clinical image analysis workflows.
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 Dental AI: FDA-Cleared Platform Explained, 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 | K251002 | Class II | Active |
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Manufacturer
- Manufacturer
- Videahealth, Inc.
Sources (1)
- FDA 510(k) K251002 24 fields · synced Sep 23, 2026