Cleared Traditional

Videa Dental Assist

K232384 · Videahealth, Inc. · Radiology

Dec 2023

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K232384 is an FDA 510(k) clearance for the Videa Dental Assist, a Analyzer, Medical Image (Class II — Special Controls, product code MYN), submitted by Videahealth, Inc. (Boston, US). The FDA issued a Cleared decision on December 15, 2023, 129 days after receiving the submission on August 8, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2070.

Submission Details

510(k) Number	K232384 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 08, 2023
Decision Date	December 15, 2023
Days to Decision	129 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