Cleared Traditional

Videa Caries Assist

K213795 · Videahealth, Inc. · Radiology
Apr 2022
Decision
136d
Days
Class 2
Risk

About This 510(k) Submission

K213795 is an FDA 510(k) clearance for the Videa Caries 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 April 21, 2022, 136 days after receiving the submission on December 6, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2070.

Submission Details

510(k) Number K213795 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2021
Decision Date April 21, 2022
Days to Decision 136 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