Cleared Traditional

Videa Perio Assist

K223296 · Videahealth, Inc. · Radiology
Feb 2023
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K223296 is an FDA 510(k) clearance for the Videa Perio Assist, a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by Videahealth, Inc. (Boston, US). The FDA issued a Cleared decision on February 6, 2023, 103 days after receiving the submission on October 26, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K223296 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 2022
Decision Date February 06, 2023
Days to Decision 103 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code QIH — Automated Radiological Image Processing Software
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code.