Cleared Traditional

Videa Dental AI

K251002 · Videahealth, Inc. · Radiology
Sep 2025
Decision
171d
Days
Class 2
Risk

About This 510(k) Submission

K251002 is an FDA 510(k) clearance for the Videa Dental AI, a Analyzer, Medical Image (Class II — Special Controls, product code MYN), submitted by Videahealth, Inc. (Boston, US). The FDA issued a Cleared decision on September 19, 2025, 171 days after receiving the submission on April 1, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2070.

Submission Details

510(k) Number K251002 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2025
Decision Date September 19, 2025
Days to Decision 171 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MYN — Analyzer, Medical Image
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2070
Definition For Information On The Myn Device, Please See: Https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers