Cleared Traditional

K231398 - VUNO Med-DeepBrain
(FDA 510(k) Clearance)

K231398 · Vuno, Inc. · Radiology
Oct 2023
Decision
142d
Days
Class 2
Risk

K231398 is an FDA 510(k) clearance for the VUNO Med-DeepBrain. This device is classified as a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH).

Submitted by Vuno, Inc. (Seoul, KR). The FDA issued a Cleared decision on October 4, 2023, 142 days after receiving the submission on May 15, 2023.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050. 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..

Submission Details

510(k) Number K231398 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2023
Decision Date October 04, 2023
Days to Decision 142 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.